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Pam Alexson single mother of 3 wonderful young adults;a special ed teacher, an RN and a senior accountant. Find out more about Pam Alexson
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  • medtronic leads

    http://wwwp.medtronic.com/Newsroom/N...218&lang=en_US

    Medtronic Pulls Defibrillator Wires Off Market
    After 5 Heart Patients Die,
    Company Suspends Selling
    Leads Prone to Fracturing
    By THOMAS M. BURTON
    October 15, 2007; Page B1 The Wall Street Journal
    Medical-device maker Medtronic Inc. is suspending sales of an electrical wire that connects the hearts of 235,000 patients world-wide to the defibrillators implanted in their chests, saying they may have contributed to five deaths.

    The wire, called a lead, is prone to fracturing within patients' blood vessels and erroneously dispatching a massive electrical jolt, the Minneapolis company said. This jolt can be uncomfortable at best, and at worst may itself have contributed to one or more of the deaths.

    However, Medtronic said it isn't recommending that most patients who have the lead -- known as the Sprint Fidelis line of defibrillator leads -- have them surgically removed. That is because the risk from the surgery to remove the wires from the veins that carry them to the heart could be more potentially dangerous than that of leaving the leads in, according to medical specialists. The company is recommending that patients who think they have the wires in their bodies should contact their doctors, who can reprogram their defibrillators to better monitor and warn of problems with the leads.

    While many details remain imprecise -- and Medtronic largely refrained from discussing the death cases -- this product removal could prove significantly larger in scope than the problems that arose in 2005 involving defibrillators and pacemakers made by Guidant Corp, now part of Boston Scientific Corp.

    In the wake of the Guidant case and similarly bad publicity concerning safety problems with Merck & Co.'s Vioxx painkiller, Medtronic's move suggests how pharmaceutical and medical-device makers are increasingly eager to get out in front of potentially damaging issues.

    In an interview, David Steinhaus, medical director of Medtronic's cardiac-rhythm disease management unit, said the company views the defects in the Sprint Fidelis leads "as a very low risk," but "we're being super-cautious and conservative about this."

    Medtronic made its decision in consultation with the Food and Drug Administration and an outside group of doctors -- including Bruce Lindsay, president of the Heart Rhythm Society, which represents specialists in the field.

    "The bottom line is we'll have to follow this and see what the numbers show," said Daniel Schultz, director of the FDA's medical device center. "The difference from a few years ago is we've had a much more cooperative relationship with the company and with the Heart Rhythm Society."

    Nevertheless, the admission could hurt Medtronic, which is the world's bigger seller of cardiac-electrical devices, such as defibrillators and pacemakers. It has about 50% of the $6-billion-plus defibrillator market. Although the company said it has yet to be sued over these flaws in the devices, lawsuits could follow as they have after earlier cardiac-device withdrawals.

    Cardiologists have long known that leads are more fragile than the devices they're connected to, and in the past, recalls of similar devices have cost companies millions. For example, Medtronic has experienced malfunctions in its heart-device leads in the 1980s and again in 1991, when it issued a safety alert to 20,000 doctors about leads' gradually losing their ability to carry electricity.

    There are 268,000 of the Sprint Fidelis leads that were implanted in patients, but it is believed that about 235,000 patients now have them in their bodies. The devices that would use the faulty leads also are known as ICD's (for implantable cardioverter-defibrillator) and CRT-D's (for cardiac resynchronization therapy-defibrillators). This latter form of complex, hybrid device not only can deliver the massive shock but can also provide extra pumping power in the hearts of patients with congestive heart failure.

    Heart defibrillators, along with the electrical leads, are designed to sense when a patient's heart has begun beating too fast, often in the lethal fast-quivering state called fibrillation. The device senses that the heartbeat has gone haywire and the shock, when appropriate, can save a patient's life by propelling the heart back into normal rhythm.

    When a Medtronic Sprint Fidelis lead fractures, three things can happen, two of them bad. It can simply beep, alerting the patient to consult his physician immediately. Or it can cause a massive, unnecessary shock akin to getting kicked in the chest by a horse. Third, it can cause the defibrillator battery to deplete, which could cause the device to fail to deliver a necessary life-saving shock.

    Medtronic's Sprint Fidelis leads are used only in cardiac defibrillators -- or complex devices with defibrillation capacity -- and not in conventional pacemakers. Some patients with congestive heart failure use devices that include this defibrillation ability, and those would be among the machines that use the Sprint Fidelis lead.

    Medtronic said it plans today to send a letter to more than 13,000 physicians world-wide. In part the letter will alert doctors that "we have identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor."

    Regarding the deaths, Medtronic officials said some involved inappropriate shocks, without specifying the cause of death. Other of the deaths, the officials said, involved battery depletion such that the defibrillator failed to dispatch an electrical shock when it was necessary to save a patient's life.

    The company said it has learned through 30-month performance data that the Sprint Fidelis had begun to fail at a greater rate than that of another top Medtronic lead, called the Sprint Quattro.

    The company's data showed that the Sprint Fidelis maintained 97.7% "viability" at 30 months, compared with 99.1% in the Sprint Quattro. Medtronic said that the numbers aren't yet statistically significant, but that "if the current lead fracture rates remain constant, it will become so over time."

    Even with a failure rate of 2.3% the problem could far exceed the risk factor in the case of the Guidant heart devices, which was generally expressed in terms of 1 in 1,000, or 1 in 5,000. Medtronic's medical director, Dr. Steinhaus, said most of the 2.3% failure rate relates to fractures as opposed to other causes. He said that historically fractures have been a concern in leads and that there have been other cases of defibrillators going off inappropriately.

    In the cases where a beep alerts patients to a problem with the leads, Medtronic says doctors could install a second lead. If there isn't room for a second lead, Medtronic says the doctors could then remove and replace the original lead.

    That is a risky operation. Two years ago, a number of heart-rhythm doctors-known as electrophysiologists-recommended patients seriously consider leaving in their Guidant devices. The thinking then was that a small risk of a device failing to work was outweighed by the possibility that removing a defibrillator could also mean in some cases having to surgically remove the lead.

    Removing a lead is a far more major concern than removing a defibrillator. Defibrillators are matchbox-sized canisters placed under the skin in the shoulder area. Normally, extracting them isn't difficult. But the wire leads, made of thin polyurethane- or silicone-coated metal alloy, are deployed in a vein and connect the device to the heart. The human body often forms scar tissue around the lead.

    Thus, removing the lead often means tearing at the scar tissue to remove it. This can lead to what some doctors estimate as a 1% possibility of a tear in the vein or the heart itself, and the possibility of dangerous or lethal bleeding. In 2004, a Dutch study found that major complications occurred in six out of 82 lead-extraction cases, including two patients who died.

    Write to Thomas M. Burton at [email protected]
    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

  • #2
    Re: medtronic leads

    I heard about this on the radio this morning and called my pacemaker clinic a little while ago; I do have one of the leads listed in the model numbers on Medtronic's site. According to the nurse, they've known about this since at least July, when I was last there for a follow-up. He said that during that visit, some fine-tuning was done on my device's programming in relation to this issue. I'm a bit peeved by this; the technician didn't make any mention whatsoever that this was being done to my device.

    I know the chances of a lead fracture are small, but still...
    Life is a banquet...and I got botulism! -- Me

    If time flies when you're having fun, will I age faster at Disneyland? -- Joel Perry

    Comment


    • #3
      Re: medtronic leads

      RRRRRRRRRRrrrrrrrrrrrrrr.....Been on hold w/Medtronics to find out if I have these things in me. Guessing I do based on my timing (got it about a year ago).

      Talk about being frustrated. I wonder if there was any correlation with those posts that we had about "random" ICD firings and this lead issue.

      Oh well, at least the on hold music is nice

      Dave

      Comment


      • #4
        Re: medtronic leads

        I also have one of the affected leads. I was told by NY Hospital this morning that I'll need to be seen in the next week of two to get some settings changed. I don't understand why they can't notify patients before we read about this in the NY Times or Wall Street Journal.

        Comment


        • #5
          Re: medtronic leads

          I want to be clear about the processes that arrive at the conclusion to issue a product removal from market. No manufacturer will issue such an action on the basis of one event. These are man made devices and subject to failures. When the problem was suspected survailance is increased and the product monitored very carefully.
          In the past few months a trend was seen and the rate of fracture trended higher then other leads so the very difficult choice was made to discontinue distribution of the leads and remove them from the market. At this time I think that Medtronic has acted appropriately in their actions.
          I would have liked to have seen the letter to the doctors go out ahead of the letter to investors - but they were done a day apart and the letter to the investors was done on Sunday and the doctors Monday. Patient letters will be sent out later this week. Given the level of severity this seems appropriate.

          Best wishes,
          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


          • #6
            Re: medtronic leads

            I was on hold for over one hour then again for 20 minutes. I gave up and I put a call into my EP ..they will get back to me.

            According to the site it is mine as well. Confused though.. the Number 6949 has other #'s as well at the end; like 694965ID. What does that mean?

            This one for me was done as an emergency in Dec. 06 as one of my original 2001 medtronic leads maxed out on voltage needs to work.

            What another pain in the old buttocks! I hope it can just be adjusted like yours Tim.
            It says on the site that patients will get their letters sent out from 10-22.

            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


            • #7
              Re: medtronic leads

              Ok, I got em too. Just got off the phone w/Medtronics, and then followed by Mayo.

              For clarification also, this is not an official "recall". It is a notification w/the addition of pulling them off the market (which usually precedes a recall).

              I asked if there was any pattern to the leads that were breaking. They did mention that there are certain techniques that doctors use to install these leads. From what I understood, the leads were failing based on certain technique(s).

              The reason I asked is I am very active (workout daily, lifting, etc..) I wanted to know if activity was associated w/the leads failing (which would seem logical).

              I also asked Medtronics for a copy of the letter sent to physicians. They would not give this to me. They said I could get a copy from my doctor up at Mayo. Mayo said they will try to get me a copy. With all of this being so new, they are dealing w/phone call after phone call.

              The most important thing I did hear was the need to have the "Patient Alerts" being turned on on the ICD. In my case the alerts associated w/leads was turned on. That helps the situation.

              Guess we will find out more as this develops...


              Dave

              Comment


              • #8
                Re: medtronic leads

                Here is the doctors letter - it is available at:
                http://www.medtronic.com/fidelis/physician-letter.html

                Urgent Medical Device Information
                Sprint Fidelis® Lead Patient Management Recommendations
                October 15, 2007

                Dear Doctor,

                This letter provides important information on Sprint Fidelis lead performance and recommendations for ongoing patient management. Our records indicate that you have implanted or are following patients with Sprint Fidelis leads (Models 6930, 6931, 6948, 6949). In consultation with our Independent Physician Quality Panel, we are voluntarily suspending distribution of Sprint Fidelis leads worldwide. This decision is based on a variety of factors detailed in this letter that when viewed together, indicate that suspension of implantation is the appropriate action. You should no longer implant Sprint Fidelis leads, and you should return any unused product to Medtronic.

                Background
                As we reported in March 2007, there are two primary locations1 where chronic conductor fractures have occurred on Sprint Fidelis leads: 1) the distal portion of the lead, affecting the anode (ring electrode) and 2) near the anchoring sleeve tie-down, predominantly affecting the cathode (helix tip electrode), and occasionally the high voltage conductor. High voltage conductor fractures could result in the inability to deliver defibrillation therapy. Anode or cathode conductor fractures (at either location) may present clinically as increased impedance, oversensing, increased interval counts, multiple inappropriate shocks, and/or loss of pacing output. The potential for defibrillation lead fracture to result in or contribute to inappropriate therapies or death has been previously reported.2 As of October 4, 2007, there have been approximately 268,000 Sprint Fidelis leads implanted worldwide. Based on current information, we have identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. We have confirmed 665 chronic fractures in returned leads. Approximately 90% of these fractures have occurred in the anode or cathode conductors, while 10% have occurred in the high voltage conductors.

                Performance Update
                Since our March 21st communication, we have examined six months additional Returned Product Analysis (RPA) and Medtronic System Longevity Study (SLS) data. In addition, we have performed extensive analysis using the Medtronic CareLink® Network (25,000 devices) [see Appendix A]. These data give us confidence in our current understanding of Sprint Fidelis’ performance.

                RPA of Sprint Fidelis leads shows a survival of 99.2% at 30 months. However, RPA overstates actual performance since it does not account for leads that are not returned. The Medtronic SLS data for the Model 6949 Sprint Fidelis lead indicate 97.7% [+1.3/-3.0] all-cause lead survival at 30 months. This is consistent with our analysis of Medtronic CareLink Network data from approximately 25,000 Sprint Fidelis leads, which indicate 97.7% [+0.6/-0.8] survival at 30 months. These survival rates are not statistically different from the all-cause lead survival of 99.1% [+0.4/-0.8] for the Model 6947 Sprint Quattro® lead at 30 months from the SLS (see Appendix B). However, we expect this difference will become statistically significant over time if the current failure rates remain constant.

                Recommendations
                Medtronic recommends you consider the following as part of routine follow-up for each patient (see AppendixC)

                To reduce the risk of inappropriate detection and therapy due to oversensing, program VF detection for initial Number of Intervals to Detect (NID) to nominal settings (18/24) or longer at physician discretion and Redetect NID to nominal settings (12/16).
                Turn ON Patient Alert™ for RV Pacing, RV Defibrillation, and SVC Defibrillation impedance. For Concerto® and Virtuoso® devices enrolled on the Medtronic CareLink™ Network, turn ON the CareLink CareAlert® notifications for these same parameters
                To optimize effectiveness of the lead impedance alert:
                Review V Pacing Lead Performance Trend to determine typical chronic impedance value for the patient (typical values for Fidelis leads should be 350-1,000 ohms).
                Program lead impedance alert threshold for RV Pacing to 1,000 ohms, if the typical chronic impedance for the patient is ≤ 700 ohms, or
                Program lead impedance alert threshold for RV Pacing to 1,500 ohms, if the typical chronic impedance for the patient is > 700 ohms.
                Program lead impedance alert threshold for RV Defibrillation and SVC Defibrillation to 100 ohms.
                The patient management recommendations set forth above should increase the likelihood that a fracture will be detected by Patient Alert and/or Medtronic CareAlert notifications and decrease the likelihood of inappropriate therapies. Based on our review of the available data, there does not appear to be a benefit to more frequent follow-up.

                Medtronic’s Independent Physician Quality Panel believes it is inappropriate to prophylactically remove Sprint Fidelis leads except in unusual individual patient circumstances.We support this position.

                Lead extraction carries risks that should be considered in patient management. Published literature suggestsmajor complications (death or surgical intervention) from lead extraction range from 1.4-7.3%.3,4 As always, with confirmed lead failure the risk of extraction should be weighed against the risk of adding an additional lead (see Appendix D).

                Additional Communication
                The HRS-recommended Physician Device Advisory Notice for this communication is attached. The information in this letter will be posted on Medtronic.com on October 15th. Consistent with the HRS5 recommendations on device advisory communications we will be informing patients with affected devices, advising them to contact you for more information. The patient letter will be sent on October 22nd.

                We are notifying regulatory agencies of this communication. We will continue to provide performance updates every six months via our Product Performance Report.

                Nothing is more important to Medtronic than patient safety. We are committed to answering your questions and keeping you informed. We regret any difficulties this may cause you and your patients. If you have questions or concerns, please contact your Medtronic Representative or Medtronic Technical Services at 1(800) 723-4636 (US).

                Sincerely,

                Reggie Groves
                Vice President, Quality and Regulatory
                Medtronic Cardiac Rhythm Disease Management

                Appendix Document Attached

                1 The two primary locations described above account for 90% of the chronic fractures identified by RPA. The remaining 10% of chronic fractures occurred in DF-1 connector leg and the proximal portion of the RV coil.

                2 Kleemann T, Becker T, Doenges K, et al., K. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of >10 years. Circulation. May 15, 2007; 115(19): 2461 - 2463.

                3 Byrd CL, Wilkoff BL, et al. Intravascular extraction of problematic or infected permanent pacemaker leads: 1994-1996. U.S. Extraction Database, MED Institute. PACE May 2000; 23(5): 927-928.

                4 Bracke FA, Meijer A, vanGelder LM. Lead extraction for device related infections: a single centre experience. Europace, May 2004; 6(3): 243-247.

                5 Recommendations from the HRS task force on device performance policies and guidelines. Carlson MD, et al. Heart Rhythm Journal 2006, 3, 1250-73.

                If you have questions or concerns, please contact your Medtronic Representative or Medtronic Technical Services at 1-800-723-4636 (US).
                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


                • #9
                  Re: medtronic leads

                  Patient Check List
                  How to find out if you have a Sprint Fidelis® lead (Models 6930, 6931, 6948, 6949):
                  Your Patient ID card should contain one of the following 4 sets of numbers: 6930, 6931, 6948, 6949. These numbers may be shown at the beginning of a longer set of numbers on your ID card.

                  What should you do, if you have a Sprint Fidelis lead:


                  The chance there is a problem with your lead is small.
                  If you have not already heard from your doctor’s office regarding this matter, we encourage you to contact your doctor’s office.
                  You are more likely to experience complications from removal than from a problem with your Sprint Fidelis lead. However, your doctor may choose to change the way your device is programmed to help reduce any potential problems. An independent panel of physician experts recommends against replacing Sprint Fidelis leads except in very unusual circumstances.
                  If you experience any unexplained changes to your health or physical symptoms:
                  We encourage you to contact your doctor’s office.

                  Should you have questions about your implantable defibrillator or pacemaker device:
                  This information applies to the Sprint Fidelis lead only, not your implanted defibrillator or pacemaker device.

                  If you have additional questions:
                  Please contact Medtronic Patient Services at 1 (800) 551-5544 x41835



                  Medtronic sincerely apologizes for any difficulties this may cause you and your family.
                  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


                  • #10
                    Re: medtronic leads

                    So if my numbers aren't in any of the sets they gave, I'm okay?? My numbers are 6947 and 5568. I had my AICD put in at Mayo 11-02.
                    Heather, 43, non-obstructive HCM, dx'd at age 14, AICD implanted 11-02, PVAI ablation done for a-fib and a-flutter 5-2010. 2nd PVAI done for a-flutter and a-tach 3-2014. 3rd PVAI for a-flutter June 2015, dr forgot to reset ICD settings and I went into vt and almost died, July 2015, July 2015-started tx work up, October 2015, put on list in Dallas and tx'd on November 14, 2015.

                    Comment


                    • #11
                      Re: medtronic leads

                      Lucky me I had a follow up appointment scheduled with my local cardiologist today. While there I went into the EP department and had them look up my records to see if my leads were on the list. THEY ARE NOT! I have nothing to be concerned about in that department for now so I am very happy!

                      To all of you who are on the list I wish you the best and am glad that the risk is generally small.

                      Peace,
                      Leon
                      God Squad co-moderator
                      Nothing is as gentle as strength and nothing is as strong as gentleness

                      Comment


                      • #12
                        Re: medtronic leads

                        Well, I am on the list. I am waiting for my EP to call me back to set up an appointment. I understand I need to have some settings changed. But this is about wires breaking right? My question is, how can a change in settings keep a wire from breaking?
                        --Kat
                        That which does not kill us, can really mess up our hair!

                        Comment


                        • #13
                          Re: medtronic leads

                          You have an older lead, so yes you should be fine.

                          I know many people are very concerned about this recall, myself included. Take the time to talk to your doctor and hear your options and make sound choices for yourself.

                          Best wishes,
                          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


                          • #14
                            Re: medtronic leads

                            I have these leads and called my EP to see what to do. I dont have an appointment until Dec 20th, which was already scheduled. Should I ask to be seen sooner? Or wait till then?

                            Comment


                            • #15
                              Re: medtronic leads

                              My post above got placed in a strang order, I had been replying to someone who asked about leads implanted in 2001...gotta love the internet!

                              If you have the leads a check with your cardiologist over the next few weeks should be fine. If you have CareLink you may want to arrange for a call in over the next few weeks.

                              I called in a Carelink today for Becca just to check the device and leads. So lets look at how a 12 year old thinks about this... I told her yesterday that her leads were placed on alert and that there is a small chance there is a problem with them, she said do I need surgery? I said maybe but not right away, she said "OK if I have to I have to".... end of story - what a great attitude and a great kid!

                              I know many of you are concerned - please take your time and talk to your doctor and take apprioriate actions.
                              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

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