If this is your first visit, be sure to check out the FAQ in HCMA Announcements. You may have to register before you can post: click the register link above to proceed. To start viewing messages, select the forum that you want to visit from the selection below. Your Participation in this message board is strictly voluntary. Information and comments on the message board do not necessarily reflect the feelings, opinions, or positions of the Hypertrophic Cardiomyopathy Association. At no time should participants to this board substitute information within for individual medical advice. The Hypertrophic Cardiomyopathy Association shall not be liable for any information provided herein. All participants in this board should conduct themselves in a professional and respectful manner. Failure to do so will result in suspension or termination. The moderators of the message board working with the HCMA will be responsible for notifying participants if they have violated the rules of conduct for the board. Moderators or HCMA staff may edit any post to ensure it conforms with the rules of the board or may delete it. This community is welcoming to all those with HCM we ask that you remember each user comes to the board with information and a point of view that may differ from that which you hold, respect is critical, please post respectfully. Thank you

Announcement

Collapse
No announcement yet.

Medtronic ICD notification of potential problem

Collapse

About the Author

Collapse

Lisa Salberg Find out more about Lisa Salberg
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • Medtronic ICD notification of potential problem

    Medtronic Issues Notification Regarding Certain Implantable Defibrillator Models


    MINNEAPOLIS, Feb. 11, 2005 – Medtronic, Inc., (NYSE: MDT) today said it is voluntarily advising physicians about a potential battery shorting mechanism that may occur in a subset of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models. In a letter to physicians, Medtronic reported that nine batteries (0.01 percent, or approximately 1 in 10,000) have experienced rapid battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function. There are no reported patient injuries or deaths.

    Devices with batteries manufactured between April 2001 and December 2003 may exhibit this shorting action. Potentially affected models are the Marquis™ VR/DR and Maximo™ VR/DR ICDs and the InSync I/II/III Marquis™ and InSync III Protect™ CRT-D devices. Approximately 75 percent of these devices were implanted in the United States. Patients with other models of Medtronic devices or these device models with batteries manufactured after December 2003 are not affected.

    As part of the company’s program to analyze products returned from physicians, Medtronic identified nine of 87,000 implanted devices (0.01 percent) with a battery design that exhibited this shorting mechanism. Based on highly accelerated company testing, Medtronic estimates that this rate may increase to between 0.2 percent and 1.5 percent over the second half of device life.

    ICDs shock or pace the heart into normal rhythm after patients suffer rapid, life-threatening heart rhythm disturbances originating in the lower chambers of the heart that can lead to sudden cardiac arrest (SCA). CRT-Ds can also provide electrical pulses to the heart’s two lower chambers to improve heart failure symptoms. An ICD or CRT-D device is surgically implanted in the chest in a procedure typically lasting one to two hours.

    “We were able to identify this possible risk through our stringent product testing,” said Steve Mahle, president of Medtronic Cardiac Rhythm Management. “Even though the potential for rapid battery depletion is extremely low, we see it as our obligation to alert all implanting physicians to the potential issue and provide ways to help them and their affected patients successfully manage the situation.”

    Medtronic began notifying physicians about the situation on Feb. 10, providing them with a list of potentially affected patients and recommending that physicians communicate with those patients and follow them closely. Medtronic is communicating this information so that physicians are aware of the potential issue and can manage it as they feel is appropriate with their individual patients.

    Additional information about this potential issue is available for physicians and patients at 1-888-775-2702 (24/7) and www.medtronicinfo.com.

    “I appreciate Medtronic’s forthright communication about this issue, which will allow implanting physicians to manage this situation with each involved patient,” said Dwight Reynolds, Chief of the Cardiovascular Section at the University of Oklahoma Health Sciences Center. “Physicians are in the best position to discuss the circumstances with device patients and ensure they have accurate information.”

    Medtronic, Inc., headquartered in Minneapolis, is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.

    - 0 -
    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
    ICD replacement

    Dr. Estes called tonight to schedule in 6 days surgery for a replacement of my potentially faulty Medtronic ICD. Since I am pacemaker dependent he doesn't want to take any chances.

    Comment


    • #3
      Faith, Best wishes for a speedy and uncomplicated recovery. I know this probably is causing a major schedule adjustment for you, but at least you can be reassured in knowing that you are being closely followed. Linda

      Comment


      • #4
        Good morning one and all.

        On Monday I am scheduled to meet with my EP people to discuss what the next steps will be regarding my ICD. I should know the if and when details regarding a replacement. It feels good knowing that I will be watched carefully. I would hate to go into v-tach or v-fib and have the darn thing choose that time to fail.

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

        Comment


        • #5
          Ditto here for me. I have to go back to see my EP AGAIN on Monday. Apparently, when I was there this past Monday and saw the Medtronic rep, the Dr. didn't know what was going on, and they hadn't formulated a plan yet. I suspect they are going to swap out my device rather than just following it closely as I am paced a good portion of the time. I think that in the meantime they will give me a magnet to test my device daily.

          As I am going in to the hospital for a couple of days next week to start Norpace, if it needs changing I will lobby for next week, but I am sure that it won't happen that way!
          Daughter of Father with HCM
          Diagnosed with HCM 1999.
          Full term pregnancy - Son born 11/01
          ICD implanted 2/03; generator replaced 2/2005 and 2/2012
          Myectomy 8/11/06 - Joe Dearani - Mayo Clinic.

          Comment


          • #6
            I know this is going to be a trying time for quite a few people. There's no easy way to deal with this type of problem, but the company seems to be working quickly to provide the safest solution in a timely manner. Hang in there, everyone. If you have questions, call your doctor and let him/her reassure you that your device is OK.

            People have 2 checks in place:

            #1 - The company has all the implant info for each patient. So, be aware of how important it is to return those occaision update forms that the company sends out. If you change contact info, let the company know so you can be contacted as needed. Most of the time, I think they even ask for a contact person who doesn't live with you just in case of a move that you may forget to let them know about.

            #2 - The doctor has his records and will check who needs to be notified as soon as the company contacts him or as soon as he hears of a problem.

            Linda

            Comment


            • #7
              My niece has the device in question. We met with our local EP team yesterday. Here is how it is breaking down.

              IF you are pacer dependent OR IF your ICD has gone off with an appropriate discharge you should have the device replaced ASAP.
              IF you have your device for primary prevention of SD and it has not gone off and you are not pacer dependent then you can check the battery daily with a magnet and replace it either at the end of battery life OR when you no longer want to check the device daily.

              The problem with the device is in the battery and the insulation between the positive and negative sides of the battery.

              Medtronic is picking up all unreimbursed costs.

              That is the latest.

              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


              • #8
                Lisa - What is Stacey going to do?
                Daughter of Father with HCM
                Diagnosed with HCM 1999.
                Full term pregnancy - Son born 11/01
                ICD implanted 2/03; generator replaced 2/2005 and 2/2012
                Myectomy 8/11/06 - Joe Dearani - Mayo Clinic.

                Comment


                • #9
                  ICD replacement

                  One further note: Since the battery depletes so rapidly if there is indeed a short, it is useful, for those of us entirely dependent on our pacemakers, to know that 1) heat in the device area and 2) beeping of the device are indicators that you need to call the doctor immediately.

                  Comment


                  • #10
                    Well, I am scheduled for replacement surgery on Friday 3/4. I was going to go into the hospital to start Norpace this weekend, but now I am going to do the whole she-bang next weekend.

                    Now I can watch the Oscars at home!
                    Daughter of Father with HCM
                    Diagnosed with HCM 1999.
                    Full term pregnancy - Son born 11/01
                    ICD implanted 2/03; generator replaced 2/2005 and 2/2012
                    Myectomy 8/11/06 - Joe Dearani - Mayo Clinic.

                    Comment


                    • #11
                      Best of luck, Cyn! I hope all goes smoothly.

                      Reenie
                      Reenie

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

                      Comment


                      • #12
                        Hi Cynthia,
                        When you see the good doctor would you give him my regards and tell him I’m in a pretty good place right now.

                        Since I saw him my kidneys had failed but are working reasonably well again. I have a water issue, and since I have to limit my diuretics I’ve switched from Verapamil to Diltiazem TR. I still have a water issue, but this arrangement seems to be working fairly well for now at least.

                        About you – take care of yourself, get your brand new ticker timer, do well on the Norpace, and by all means heal quickly and well.
                        Burt

                        Comment


                        • #13
                          Thanks, Burt. I am glad to see you back here as well.

                          Actually, I am going to have all of my adjustments done with my EP's practice at Good Samaritan hospital on the recommendation of Dr. Siegel. One of the partners of my EP was the first guy who in the 1980s who started treating HCM with Norpace, so Siegel thinks that he should be the one to administer it to me. Now I have yet another Dr. to add to my roster! I think that I rival you in the sheer number of specialists that I see now. I believe I am up to 10 or 11.

                          Ah....the blessings of middle age...
                          Daughter of Father with HCM
                          Diagnosed with HCM 1999.
                          Full term pregnancy - Son born 11/01
                          ICD implanted 2/03; generator replaced 2/2005 and 2/2012
                          Myectomy 8/11/06 - Joe Dearani - Mayo Clinic.

                          Comment


                          • #14
                            Hi Cynthia,
                            Middle aged? Me? My goodness – you want me to live until I’m 144? Isn’t that a bit much? Heck, my daughter is probably older then you – and she don’t need a new battery to get all charged up with either.

                            And as far as doctors go, as near as I can figure I’m now down to eleven – not counting the ones I no longer see on a regular basis, like the gastroenterologist, pulmonologist, and a surgeon or two. Of course Shirley has taken up the slack by adding three new ones, and since she doesn’t drive, my appointment calendar is still rather full. Then again if I wasn’t running to doctors all the time I might even have enough free time to get into trouble with. I guess that’s life in the ‘not so fast’ lane.

                            Now I want to hear all about how easy the procedure and switching to the new medication goes. I hope it works even better then you hope for.
                            Burt

                            Comment


                            • #15
                              Hi, I just talked to the people at medtronics. It looks like my ICD is one of the ones that has been recalled. I am waiting to talk to the other people at medtronics to find out what to do next. I have not had any of the heat at the ICD site. It has fired 2 time but no one has said that my power is low.

                              I will wait and see what happens. If nothing eles I may get a few days off work and get a new story. Have a great day.
                              Donna B. HCM & ICD. 2 sons with HCM. Brother passed away from HCM at the age of 39. Mother has HCM.

                              Comment

                              Today's Birthdays

                              Collapse

                              Working...
                              X