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Guidant Didn't Disclose a Flaw in Defibrillator for 3 Years

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  • Guidant Didn't Disclose a Flaw in Defibrillator for 3 Years

    http://www.nytimes.com/2005/05/24/bu...rtner=homepage

    By BARRY MEIER
    Published: May 24, 2005
    A medical device maker, the Guidant Corporation, did not tell doctors or patients for three years that a unit implanted in an estimated 24,000 people that is designed to shock a faltering heart contains a flaw that has caused a small number of those units to short-circuit and malfunction.


    Allen Brisson-Smith for The New York Times
    Lee Oukrop held a photograph of his son, Joshua, whose heart defibrillator was found after death to be flawed. Another son, Jacob, is at right.

    The Potential for Defibrillator FailureThe matter has come to light after the death of a 21-year-old college student from Minnesota, Joshua Oukrop, with a genetic heart disease. Guidant acknowledges that his device, known as a defibrillator, short-circuited. The young man was in Moab, Utah, on a spring break bicycling trip in March with his girlfriend when he complained of fatigue. He then fell to the ground and died of cardiac arrest.

    Guidant subsequently told his doctors that it was aware of 25 other cases in which the defibrillator, a Ventak Prizm 2 Model 1861, had been affected by the same flaw. Guidant said it had changed its manufacturing processes three years ago to fix the problem. The physicians say that had they known earlier, they would have replaced the unit in their patient because he was at high risk of sudden death. His death is the only one known.

    A defibrillator is surgically implanted in the chest under the skin. It sends out an electrical charge to try to shock a chaotically beating heart back into normal rhythm.

    In interviews in recent days, a top Guidant executive, Dr. Joseph M. Smith, said that the company had not seen a compelling reason to issue an alert to physicians about the defibrillators because the failure rate was very low and replacing the devices might pose greater patient risks.

    But late yesterday, when told that The New York Times was preparing an article about the device, the company issued an advisory to doctors about it. Guidant is recommending that the unit not be replaced because of the electrical problem.

    The episode highlights an important issue: Doctors and patients are not always told when a medical device maker has data indicating that its product has a flaw that, while rare, poses potential dangers. Also, companies are not required to report immediately all safety modifications to the Food and Drug Administration.

    In February another defibrillator maker, Medtronic Inc., notified doctors that the battery used in one of its models was draining far faster than expected. At that time, the company had received nine reports among 87,000 affected units, an incidence of failure of 0.01 percent, which is lower than the figure for the affected Guidant defibrillators, which is 0.07 percent, based on 37,000 units manufactured before the modification. The Medtronic devices have not been associated with a death or an injury. However, in its advisory to doctors, Medtronic said its testing indicated that the problem could worsen over time and affect 0.2 percent to 1.5 percent of its units. The Guidant problem, Dr. Smith said, has remained constant over time.

    One cardiologist said that Medtronic officials told him that physicians had replaced over 11,000 of the devices; a company spokeswoman said the company planned to release data today.

    Dr. William H. Maisel, who has studied how doctors respond to device alerts, said that companies considering an alert face competing concerns over the cost of replacement versus harm to their reputations. As a result, Dr. Maisel, a cardiologist at Brigham and Women's Hospital in Boston, said there was the potential for a "huge conflict of interest."

    The Guidant executive, Dr. Smith, who is the chief medical officer of Guidant's cardiac rhythm management division, rejected any suggestion that financial or liability concerns had influenced the company's decision.

    He said that the Model 1861 was among the most reliable defibrillators available, adding that Guidant believed that it would cause more harm than good by publicizing the issue because replacement defibrillators might not perform as well and because surgery also posed risks. While fatalities during defibrillator implantation are extremely rare, the procedure poses an infection rate of about 1 percent.

    "We choose to extraordinarily communicate when we have a product that does not live up to our expectations," Dr. Smith said. He added that issues that could improve patient outcomes would also warrant an alert to doctors. "In this case, neither condition was met," he said.

    Guidant, which is based in Indianapolis, is one of the largest makers of medical devices, with $3.8 billion in sales last year, almost half of that coming from implantable defibrillators. In December, Johnson & Johnson announced it planned to buy Guidant in a deal worth $25.4 billion.


    The Potential for Defibrillator FailureDefibrillators need to be replaced every five or six years because their batteries drain.

    Implanted defibrillators are among the fastest-growing group of medical devices; this year alone, more than 200,000 patients are expected to get one. In 2001, Vice President Dick Cheney received one made by Medtronic. A defibrillator can cost up to $25,000 and hospital and doctor costs can run another $15,000.

    In interviews, doctors in Minnesota who treated Joshua Oukrop said they were angered by Guidant's decision not to notify physicians because they said the company had received enough reports about the flaw to establish a pattern and because high-risk patients could suffer potentially catastrophic results.

    Dr. Barry J. Maron of Abbott Northwestern Hospital in Minneapolis said that Dr. Smith was simply using numbers to support his stance.

    "It is a statistical argument that has little to do with real people," Dr. Maron said. He also said that the numbers reported to Guidant might understate the situation because product problems could go undetected or might not be reported.

    The short circuit can occur when the device builds a charge to deliver the type of high-energy shock needed in emergency situations. In three cases, when doctors intentionally induced abnormal heart rhythms during routine checkups, the Guidant device failed to work, forcing doctors to rescue those patients by jolting them with the type of external defibrillator used in emergency rooms.

    All the electrical malfunctions involving the particular model occurred in units produced during a two-year period before mid-2002, when the company fixed the flaw. The problem has not happened in any devices made since.

    F.D.A. regulations permit companies to inform the agency in two different ways about a manufacturing modification to improve safety, either while the company is making it or later, when a device maker files its annual report with the agency.

    A Guidant spokeswoman, Annette Ruzicka, said that it reported the November 2002 change as part of an annual report submitted to the F.D.A. in August 2003.

    As reports of individual problems came in, Guidant filed them with the F.D.A.

    Dr. Robert G. Hauser, also of Abbott Northwestern Hospital in Minneapolis, said he recently started alerting cardiologists about the Guidant unit through a database he maintains that collects data about defibrillator and pacemaker failures.

    He and Dr. Maron have also submitted an article about their patient's case to a medical journal. One of those contacted, Dr. David S. Cannom, who sits on Guidant's board of outside medical advisers, said in an interview that he believed that doctors should have all the facts.

    He said that while risks posed by the device were small enough to argue against replacement in many patients, that calculus could shift substantially for high-risk ones.

    "At the end of the day, you have to come down on the side of full disclosure," said Dr. Cannom, the director of cardiology at Good Samaritan Hospital in Los Angeles.

    Over all, implanted defibrillators have a good record of reliability and are credited with saving countless lives, but the Minnesota case appears to illustrate the consequences that can result when company officials decide not to directly alert doctors to a problem, even for reasons that they believe are justified. Joshua Oukrop suffered from a relatively common genetic disease, hypertrophic cardiomyopathy, which can cause abrupt cardiac arrest.

    One of his doctors, Dr. Maron, is an expert on the condition and a leading proponent of using implanted defibrillators to reduce deaths caused by the disease. Dr. Hauser, who was also involved in the young man's treatment, is a former chief executive of Cardiac Pacemakers Inc., one of five companies that was spun off by Eli Lilly in 1994 to form Guidant.

    Joshua's father, Lee Oukrop, said that when his son was 17, he began fainting and falling down at marching band practice or while playing softball. The heart disease had previously been diagnosed in an older son, Jacob, so Mr. Oukrop took Joshua to see Dr. Maron in 2001. The physician determined that the teenager's condition was severe, and an implant was soon performed.


    The Potential for Defibrillator FailureMr. Oukrop, a millwright who lives in Grand Rapids, Minn., a small town about 80 miles west of Duluth, said that Dr. Maron had said "that this was the fix and that Josh could live with this."

    For over three years, Mr. Oukrop said, his son's life was normal. He attended college, where he was studying to be a teacher, and was an outdoor enthusiast who hiked, snowboarded and bicycled. Like other defibrillator users, he saw his doctors every three months so they could check the device.

    When Guidant inspected the device after Joshua's death, it found that the unit had short-circuited when it was charging up. Because the short circuit also destroyed the device's memory, it is not possible to know whether the failure occurred while Joshua Oukrop was in cardiac arrest or at some other point.

    "There was evidence of a device malfunction," said Dr. Smith, the Guidant executive.

    After hearing a presentation a few weeks ago by Dr. Smith about the device, Dr. Maron, the genetic heart disease expert, said he asked what Guidant planned to tell doctors. "The answer was nothing," Dr. Maron said.

    Dr. Smith, the Guidant executive, said the overall reliability rate of the Prizm 2 model exceeded company specifications both before and after the wiring fix.

    So far, Dr. Maron and Dr. Hauser have notified dozens of their patients who got the Guidant unit to discuss possibly replacing it.

    Dr. Maron said that now that the physicians were aware of the problem they had to consider, besides patient safety, their own responsibilities and potential liability.

    Last week, Lee Oukrop, who has the same genetic heart disease as his sons and had the same Guidant device as Joshua, underwent a replacement procedure. He also said he was likely to hire a lawyer soon.

    'Whoever made this decision at Guidant, I pray he doesn't have a son who this happens to," Mr. Oukrop said.
    Knowledge is power ... Stay informed!
    YOU can make a difference - all you have to do is try!

    Dx age 12 current age 46 and counting!
    lost: 5 family members to HCM (SCD, Stroke, CHF)
    Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
    Therapy - ICD (implanted 97, 01, 04 and 11, medication
    Currently not obstructed
    Complications - unnecessary pacemaker and stroke (unrelated to each other)

  • #2
    Well isn't this nice that is exactly what mine is, so they are just not shocking? i guess i better call the ICD clinic, thanks Lisa

    Shirley
    Diagnosed 2003
    Myectomy 2-23-2004
    Husband: Ken
    Son: John diagnosed 2004
    Daughter: Janet (free of HCM)

    Grandchildren: Drew 15,Aaron 13,Karen 9,Connor 9

    Comment


    • #3
      Ok I called the people that made this ICD and they are recommending i get mine checked i seem to have the very same one the young man had


      Guidant was very nice and explained and you could tell she was choosing her words carefully, i told her it was no big deal i would go get it checked

      Shirley
      Diagnosed 2003
      Myectomy 2-23-2004
      Husband: Ken
      Son: John diagnosed 2004
      Daughter: Janet (free of HCM)

      Grandchildren: Drew 15,Aaron 13,Karen 9,Connor 9

      Comment


      • #4
        I think the key portion of this article is :

        The episode highlights an important issue: Doctors and patients are not always told when a medical device maker has data indicating that its product has a flaw that, while rare, poses potential dangers. Also, companies are not required to report immediately all safety modifications to the Food and Drug Administration.
        Many of us here need to trust our devices, even though we are well aware they are man made and may be not be 'perfect'. However we as patients have a right to expect full disclosure and honest information from those in charge of these manfucaturers. Several months back Medtronic had a problem with some devices and notified everyone to get them checked, that was the right thing to do. Withholding information is NOT the right thing to do when dealing with ones health.

        I am sure this article may be of concern to some people. If you have the device mentioned in the article contact your doctor for further information. This is breaking information and it may be a few days until a clear path is made for the doctors to know how to handle this matter.

        When I know anymore I will advise.

        Be well,
        Lisa
        Knowledge is power ... Stay informed!
        YOU can make a difference - all you have to do is try!

        Dx age 12 current age 46 and counting!
        lost: 5 family members to HCM (SCD, Stroke, CHF)
        Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
        Therapy - ICD (implanted 97, 01, 04 and 11, medication
        Currently not obstructed
        Complications - unnecessary pacemaker and stroke (unrelated to each other)

        Comment


        • #5
          Wow , that is also my devise. I was told by Guidant that it is not a recall and they are advising no change or any action neccessary at this point. They stated that all EP's will recieve a letter that went out yesterday with guidelines and reccomendations for these devises that are older the 3 years.

          I will have my NIPS next month and am now glad that mine is baseline tested via NIPS on a yearly basis.

          Will let you know any more that I hear.

          Pam
          Dx @ 47 with HOCM & HF:11/00
          Guidant ICD:Mar.01, Recalled/replaced:6/05 w/ Medtronic device
          Lead failure,replaced 12/06.
          SF lead recall:07,extracted leads and new device 2012
          [email protected] Tufts, Boston:10/5/03; age 50. ( [email protected] 240 mmHg ++)
          Paroxysmal A-Fib: 06-07,2010 controlled w/sotalol dosing
          Genetic mutation 4/09, mother(d), brother, son, gene+
          Mother of 3, grandma of 3:Tim,27,Sarah,33w/6 y/o old Sophia, 5 y/o Jack, Laura 34, w/ 5 y/o old Benjamin

          Comment


          • #6
            This is the part that worries me (besides Guidant's lack of disclosure which is criminal):
            When Guidant inspected the device after Joshua's death, it found that the unit had short-circuited when it was charging up. Because the short circuit also destroyed the device's memory, it is not possible to know whether the failure occurred while Joshua Oukrop was in cardiac arrest or at some other point.
            I'm wondering what his last NIPS or interogation said that they didn't catch it.

            Comment


            • #7
              Hey, I have the lucky number too! And I was feeling so very safe. Great! Guess it's time to contact my cardiologist. Thanks for the update, everyone. I'll let you know what they say.

              Sue

              Comment


              • #8
                Is it correct to assume that if Guidant hadn't been questioned by a few doctors, they still would not have revealed the problem? Linda

                Comment


                • #9
                  Linda it sure sounds like that doesn't it, my hubby is not too happy with this news at all, I told i may still be safe mine may be fine but i think i want another brand in me being they knew they had a problem and never said anything

                  Shirley
                  Diagnosed 2003
                  Myectomy 2-23-2004
                  Husband: Ken
                  Son: John diagnosed 2004
                  Daughter: Janet (free of HCM)

                  Grandchildren: Drew 15,Aaron 13,Karen 9,Connor 9

                  Comment


                  • #10
                    AS IF I DIDN"T HAVE ENOUGH ISSUES!!!

                    When I was in the hospital a couple of weeks ago the nurses spotted v-tach on their monitors. They came in guns blazing. Quite startling when your on the pot trying to go to the bathroom if you know what I mean! I questioned my cardio about it they interrogated it and the guidant rep said nothing had happened or been recorded. So my cardio said that their monitors must have been wrong. But, now I'm beginning to question that. I'm printing the article out and taking it straight to the cardiologist tomorrow.

                    To be honest I'm am getting more and more disenchanted with the health care industry!

                    Mary S.

                    Comment


                    • #11
                      This is from the Guidant Web Site:

                      VENTAK PRIZM 2 DR Patient Information
                      Foremost in your mind and ours is the safety and well being of patients. As a result of recent communications from sources other than Guidant regarding the VENTAK PRIZM® 2 DR ICD, we want to provide clarity and assure you that clinical performance of Guidant's VENTAK PRIZM 2 DR ICD continues to exceed design expectations and ranks overall as one of the most reliable ICD products available.

                      Guidant wants to assure you that the VENTAK PRIZM 2 DR implantable defibrillator continues to demonstrate exemplary overall reliability performance. Guidant's VENTAK PRIZM 2 DR ICD continues to exceed design expectations and ranks overall as one of the most reliable ICD products available.
                      Guidant recommends that physicians continue normal monitoring for all patients with VENTAK PRIZM 2 DR ICDs.
                      Guidant does not recommend replacement of these devices prior to the normal elective replacement indicators. Please contact your physician if you have additional questions


                      The repetitive bold type face kinda seems like damage control to me? Also, in the article their failure rates were higher than medtronic's and they issued a recall. Why is our numbers higher but not allowed to have it replaced. I guess a medtronic patient is more valuble than a guidant one (sorry sarcasm i guess).

                      Mary S.

                      Comment


                      • #12
                        --------------------------------------------------------------------------------

                        May 25, 2005
                        F.D.A. Meets With Maker of Flawed Heart Device
                        By BARRY MEIER
                        Officials of the Food and Drug Administration and the Guidant Corporation met yesterday to discuss a company defibrillator that has partly or totally failed in 26 cases because of an electrical flaw, including an instance in March that involved the death of a college student.

                        The meeting followed the disclosure that Guidant had not informed doctors for three years about a design flaw in the implantable defibrillator, known as a Ventak Prizm 2 Model 1861, or told them that it had changed its manufacturing process in 2002 to fix it.

                        A defibrillator, which is surgically implanted under the skin in the chest, sends out a charge to try to shock a chaotically beating heart back into rhythm.

                        "We did meet with the company and are continuing discussions with them about this product," said Kathleen K. Quinn, a spokeswoman for the F.D.A. She declined to elaborate.

                        A Guidant spokesman did not respond yesterday to questions about issues discussed at the meeting. But the company has said that it followed all F.D.A. guidelines in reporting problems about the device to the agency.

                        Late Monday, Guidant sent out an advisory to doctors nationwide about the device and recommended that it not be removed because of the electrical problem. Guidant said it believed that a substitute device would not perform better than a Model 1861 and that the implant procedure posed risks.

                        The company sent out its notification Monday as The New York Times was preparing to publish an article about the device.

                        In trading yesterday on the New York Stock Exchange, Guidant stock fell 43 cents, to $73.74 a share. It was the third most actively traded stock.

                        In December, Johnson & Johnson said that it planned to buy Guidant, one of the nation's biggest makers of medical devices, in a deal worth $24.5 billion. Yesterday, Johnson & Johnson, based in New Brunswick, N.J., issued a statement saying that it remained committed to buying Guidant.

                        Guidant, based in Indianapolis, said yesterday that if doctors and patients choose to replace the device early, the company would honor its warranty on a pro-rated basis. Defibrillators need to be replaced every five or six years because their batteries drain. The units at issue were produced from 2000 until mid-2002.

                        Dr. Ronald Berger, a professor of medicine at Johns Hopkins University in Baltimore and a medical adviser to Guidant, said that he did not plan to advise his patients that the device be replaced because the electrical problem was so rare. Other heart specialists, however, said they might take a different approach in patients at high risk of sudden cardiac arrest because the unit's failure could occur unexpectedly.

                        Both Dr. Berger and other physicians said that they would also take patients' wishes into account.

                        "I think it very likely we will change out a lot of these devices," said Dr. Robert Rea, the director of the implantable cardiac service at the Mayo Clinic in Rochester, Minn. The 21-year-old student who died, Joshua Oukrop, had a relatively common genetic heart disease, hypertrophic cardiomyopathy, that can cause sudden death. Guidant acknowledges that his device malfunctioned because of the short-circuit problem, though it is not possible to know when the unit was disabled.

                        Another defibrillator maker, Medtronic, said yesterday that doctors worldwide had replaced 13,000 of one of its models since it announced in February that it had a battery-related problem. While there are few current complaints, the company, based in Minneapolis, said that over time the problem would affect 0.2 percent to 1.5 percent of those units.

                        To date, the Guidant problem has affected 0.07 percent - 26 units - of the 37,000 produced before the fix was made, and the company said that the rate had not increased over time.

                        Medtronic, which is covering the full cost of a replacement device, said yesterday that it had incurred $18 million in costs to date in connection with replacements and had put $17 million in a reserve to cover potential future costs.
                        Knowledge is power ... Stay informed!
                        YOU can make a difference - all you have to do is try!

                        Dx age 12 current age 46 and counting!
                        lost: 5 family members to HCM (SCD, Stroke, CHF)
                        Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
                        Therapy - ICD (implanted 97, 01, 04 and 11, medication
                        Currently not obstructed
                        Complications - unnecessary pacemaker and stroke (unrelated to each other)

                        Comment


                        • #13
                          Saint Paul Pioneer Press (Minnesota)

                          May 25, 2005 Wednesday

                          SECTION: MAIN; Pg. 1A

                          LENGTH: 1004 words

                          HEADLINE: In Business: Medical, financial communities' reaction is mixed to news that Guidant delayed disclosure of faulty device. 'THIS WILL SAVE YOUR LIFE'; That's what Lee Oukrup told his son of the defibrillator that failed.

                          BYLINE: BY JENNIFER BJORHUS; Pioneer Press

                          BODY:

                             Lee Oukrop had just fallen asleep that night in March when the doorbell rang.
                          Itasca County Sheriff Pat Medure stood on his doorstep, asking if Lee had a son named Joshua who was in Utah.

                             "I looked at him and I said, 'No, no, no, no,' " Oukrop said Tuesday. "I said, 'It couldn't have happened. He had a defibrillator in him.' "

                             Disbelief has given way to questions for Oukrop, a Grand Rapids father struggling to understand why 21-year-old Joshua died suddenly while mountain biking in Utah. On Tuesday, the millwright, whose son suffered from heart disease, found himself at the center of a swirling medical controversy after the New York Times ran an article about Joshua's faulty Guidant Corp. implantable cardiac defibrillator.

                             According to the Times, the medical device maker didn't tell doctors or patients about a flaw that caused a small number of Guidant's Ventak Prizm 2 Model 1861 defibrillators to short-circuit until three years after it had changed its manufacturing processes to fix the problem. Joshua's death is the only one known, according to the report, but the device has been implanted in an estimated 24,000 people.

                             Oukrop, 52, hired an attorney Monday to investigate his son's death. Guidant was to meet with the U.S. Food and Drug Administration on Tuesday to discuss malfunctions with the defibrillator, which was developed at the company's cardiac rhythm management division in Arden Hills.

                             Guidant, based in Indianapolis, didn't respond to phone calls Tuesday. It told the New York Times it didn't disclose the problems to doctors because the risks were so low. It knew of only 25 other cases where the device was flawed.
                          Guidant did disclose the problem to the FDA.

                             Guidant has posted a notice about the Ventak Prizm 2 defibrillator on its Web site. "Guidant wants to assure you that the Ventak Prizm 2 implantable defibrillator continues to demonstrate exemplary overall reliability performance," the notice said. "Guidant does not recommend replacement of these devices prior to the normal elective replacement indicators."

                             Lee Oukrop and his surviving son, 25-year-old Jacob, also have the heart disease known as hypertrophic cardiomyopathy. The father had the Ventak Prizm 2 implanted in his chest, but had it replaced Thursday with a different device made by Guidant's rival, Fridley-based Medtronic Inc. Jacob Oukrop had his first defibrillator, also a Medtronic device, implanted five weeks ago.

                             "We're getting a lot of calls from patients," said Dr. Robert Hauser, a senior consulting cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, where the Oukrops were treated.

                             The heart institute mailed letters last week to 41 patients with the Ventak Prizm 2 Model 1861 defibrillator, saying that doctors wanted to discuss the device with them, Hauser said. They might send out more letters as they track down others with the device. He said doctors don't know how many devices they will recommend replacing.

                             Guidant should have informed doctors and patients immediately about the electrical flaw, Hauser said.

                             "We need to press on and change how these problems are dealt with in the industry," Hauser said. If Joshua Oukrop's device had been functioning properly, Hauser said, "he would have been resuscitated, in all probability."

                             The Oukrops have a relatively common genetic heart disease, a largely inherited condition in which the heart muscle thickens for an unknown reason and affects blood flow. It can severely interfere with normal electrical impulses in the heart and can cause cardiac arrest and heart failure. Defibrillators shock an abnormally beating heart back to normal.

                             Oukrop, whose wife died two years ago of colon cancer, said Tuesday he was overwhelmed by the media attention to his son's death. But he was also pleased, he said, because people need to know how such product defects are handled.

                             "Deep down, I think this will do nothing but good," Oukrop said. "It's just been unbelievable, and I wouldn't wish it on anybody to have to go through this.
                          "

                             At the top of Oukrop's mind are the assurances he gave Joshua at age 17 about having an implantable cardiac defibrillator, or ICD, put in his chest.

                             "I sat down with my son and I gave him my personal guarantee that this ICD would save his life, that he would be around for many, many years," Oukrop said.
                          "I told him, 'you've got to have it, this will save your life.' "

                             Joshua was a junior at Bemidji State University who was studying education.
                          Oukrop described his slender, pony-tailed son as an outdoorsman who biked to school every day and wanted to be a nontraditional teacher. Joshua spent two summers as a camp counselor at the Deep Portage Conservation Reserve in northern Minnesota, a nonprofit organization that teaches such skills as shoreline restoration, outdoor ethics and snowshoe making, Oukrop said.

                             He also earned money cooking for restaurants such as Perkins and Dave's Pizza. He loved music, from Bob Dylan to Big Wu, and was well known for giving big hugs.

                             Joshua met his girlfriend last fall after transferring from Itasca Community College to Bemidji State, Oukrop said. They had originally planned to spend spring break in New Orleans with a group of friends, he said, but those plans fell apart. The two instead drove to Moab, Utah, to go mountain biking.

                             They rented bikes and were about 4 miles down a 14-mile loop when Joshua complained about being winded, Oukrop said. They stopped, chatted and resumed biking, Oukrop said.

                             Joshua's girlfriend had pedaled a bit ahead when Joshua called out again to stop because he didn't feel right. Oukrop said she turned around to see Joshua fall backward off his bicycle. She ran back to him and couldn't find a pulse, Oukrop said. She started CPR, but a paramedic who happened by on the trail told her to stop because Joshua was gone.

                             "I can't even imagine what that poor young girl went through," Oukrop said.
                          Knowledge is power ... Stay informed!
                          YOU can make a difference - all you have to do is try!

                          Dx age 12 current age 46 and counting!
                          lost: 5 family members to HCM (SCD, Stroke, CHF)
                          Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
                          Therapy - ICD (implanted 97, 01, 04 and 11, medication
                          Currently not obstructed
                          Complications - unnecessary pacemaker and stroke (unrelated to each other)

                          Comment


                          • #14
                            Story here

                            Heart Device Maker Mum On Flaw


                            New York, May 24, 2005



                            "Whoever made this decision at Guidant, I pray he doesn't have a son who this happens to." Lee Oukrop
                            (AP) The maker of an internal heart defibrillator admits it waited three years before telling some 24,000 patients and their doctors about an electrical problem that caused a small fraction of the implanted devices to short-circuit.

                            The admission by Indianapolis-based Guidant Corp., reported Tuesday by The New York Times, came about after a Minnesota college student died on a spring-break bicycling trip in March.

                            The death of 21-year-old Joshua Oukrop of Grand Rapids, who had a genetic heart disease, is the only one known.

                            Guidant disclosed the flaw in its Ventak Prizm 2 Model 1861 to Oukrop's doctors and told them about 25 other cases in which the defibrillator had malfunctioned. It did not, however, issue an alert to physicians until it learned the newspaper was preparing a story on the defibrillator.

                            The company is recommending that the unit not be replaced.

                            Guidant had not seen a compelling reason to issue an alert to physicians because the malfunction rate was low and replacing the devices might pose greater patient risks, Dr. Joseph M. Smith, a Guidant executive, told the Times.

                            "We choose to extraordinarily communicate when we have a product that does not live up to our expectations," Smith said, adding issues that could improve patient outcomes would also warrant an alert to doctors.

                            "In this case, neither condition was met," he said.

                            Oukrop's father, Lee Oukrop, who has the same genetic heart disease, had the same defibrillator until last week, when he underwent a replacement procedure.

                            "Whoever made this decision at Guidant, I pray he doesn't have a son who this happens to," Lee Oukrop said.

                            Electrical malfunctions involving Ventak Prizm 2 Model 1861 occurred in units produced during a two-year period before mid-2002, when the company fixed the flaw. The problem has not happened in any devices made since.

                            In February, Medtronic Inc., based in Fridley, Minn., told doctors that the battery used in one of its defibrillators was draining too fast. No deaths or injuries have been associated with the Medtronic model.

                            Implanted defibrillators, such as the one Vice President Dick Cheney has, shock the heart back into a normal rhythm when it starts beating irregularly.

                            Guidant is one of the largest makers of medical devices, with $3.8 billion in sales last year, almost half coming from implantable defibrillators.
                            Reenie

                            ****************
                            Husband has HCM.
                            3 kids - ages 23, 21, & 19. All presently clear of HCM.

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