Boston Scientific Defibrillators May Have Deadly Defect: Report

Another major internal defibrillator may have a flaw that could be responsible for at least one death. 

Boston Scientific indicates that a malfunction in its Cognis implantable cardioverter-defibrillator (ICD) may have contributed to the death of at least one patient, raising concerns over both the Cognis and Teligen ICDs.

The death, reported in a recent Product Performance Report (PDF), allegedly occurred when the device’s transformer malfunctioned. However, Boston Scientific has not indicated that a recall will be issued for the device.

Boston Scientific warned that the malfunction occurred during the high-voltage charging cycle of the device, leading to loss of telemetry, bradytherapy, tachytherapy and remote follow-up. At least four patients have reported feeling the device get suddenly hot at the implant site.

The company claims that the malfunction is rare and that the ICDs are still safe. Out of about 233,000 Cognis and Teligen ICDs sold, only 26 have reportedly malfunctioned. The transformer component blamed for the problem is present in the Cognis CRT-D N118/N119/N120/P106/P107/P108, Teligen DR ICD E110/E111/F110/F111, and Teligen VR ICD E102/E103/F102/F103 models.

The warning comes as St. Jude is still trying to quell claims that defects lead to the deaths of 22 patients with its Riata and Riata ST ICDs. A St. Jude Riata defibrillator lead recall was announced late last year after reports that the leads were poking through the protective insulation.

Last month a medical device alert sent out by regulators in the U.K. warned of potential battery problems in Medtronic EnTrust defibrillators.

The problems are the latest in a string of issues involving ICDs. The internal defibrillators are designed to be implanted near a patient’s heart, monitor his or her heart rhythms and give life-saving electrical shocks if necessary.

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  1. arleen Reply

    my husband had defibrillator from 2005 to 2010 and then another from 2010 till 2012. never being shocked. Then his cardiologists suggested he have a new one calling it the “ROLLS ROYCE’ of ICDs. He consented and was admitted to Deborah Heart center and had this new ICD on July 22, 2012. Within a month he began to receive shocks and the doctor adjusted the device and then the shocks came more frequently and another adjustment. This went on for eight months and more frequent shocks. Meanwhile my husband was afraid to even get out of bed. He went back into the hospital on March 17, 2013 and was transferred to Deborah again for a procedure to correct this problem. Unfortunately, two days before the procedure was to be done he was in the bathroom and was shocked, hit his head and never regained consciousness. I cannot help attribute his death to Boston Scientific and the doctors along with an attendant who was not supposed to leave him alone but stated to me and my daughter “I only left the room for 30 seconds”.
    I believe the ICD was defective and wish to pursue this if I can find a
    legal team willing to handle this claim.

  2. Renee Reply

    boston scientific icd model e110 failed to send out shock to return heart to safe rhythm. It did nothing and also failed to detect the activity of her heart leading up to her death. Autopsy reviewed no cause of death and was reported as undetermined. She had two malfunctioning misfires sending inappropriate shocks to her heart 2 times in the 18 months she had it. It was readjusted and she went on her way. She died May 13, 2012. I’m seeking consultation and representation

  3. Tom Reply

    My dad had a heart attack in July 2014. The Drs decided it best to install a Boston Scientific Defibrillator in an effort to control his heart rhythm, and avoid another heart attack by shocking his heart into a normal rhythm. Dad was in rehab and making significant progress and couldn’t wait to get back home. He felt a certain ease of knowing that he had a safety net that would monitor his heart for abnormalities, and if needed, shock his heart back into the correct rhythm. Unfortunately he started into another heart attack and the Defibrillator didn’t work at all. After this machine failed to work, dads health started to deteriorate rapidly. He died on September 8th. I’m confident that if the Defibrillator would have worked, that he would have continued onto the road to recovery.
    When the Drs removed his Defibrillator, and then took it apart to analyze, they concluded that it malfunctioned because the entire unit was defective. That it was scrap before they ever installed it.

  4. Tomk Reply

    I’m wondering if you have had any resolve to your statement? It seems as if you and I have been dealing with the same issues.

  5. Tom Reply

    While enroute to Anchorage form Homer last week to catch a flight to the lower 48, my wife was alerted by her cardiac physician’s office (due to her ICD beeping for 4 days and her telecall for inquiry as to why) that her Boston Scientific device was using more power than necessary and was going to die of power in 28 days. As a result she was told that her unit would need replacement post haste. When we returned from the lower 48 four days later she was rushed to the hospital in Anchorage where her device was changed out. We were informed that there was notification several months earlier that her device was on a recall list. We were not notified at all of this recall and she had to call her physician due to the device beeping to learn of the problem. Hopefully her new device will be more reliable and provide the 8-10 years of service as stated before a battery change. This appears to be blatant negligence on behalf of the ICVD manufacturer as they did not notify us of the problem in advance. I we were traveling and she needed a “shock” I am doubtful that she would be alive today. Shame on Boston Scientific!

  6. dennis Reply

    shortly after receiving my boston scientific pacemaker and defibulator I began to experience lightheadedness and near blackouts when riding over rough washboard roads. over the last five yrs the problem has become worse.lately riding on normal sts causes the same effects. the bouts of dizziness have gotten worse and resulted in a complete blackout and a shock from the device. ive been told that the machine senses jarring as physical exertion and causes the heart to speed upp lately, however, ive monitored my pulse during these episodes and found that my pulse rate did not increase. instead, my heart rate becomes very irregular.. if I stop and walk for awhile it improves but it takes hours to return to normal.i am absolutely certain as to what causes the problem but my dr apparently doesn’t believe me . I’d like to know if anyone else has experienced similar symptoms. my device is a boston scientific icd model e110 with two Guidant leads, model0185 and model 4470.

  7. Betsy Reply

    I’m so scared. I’m do sick and tired of being told that much is in my head… of course it’s partially true! I was only 16 (now 27) when I has my first arrhythmia and cardiac arrest. I have genetic Long QT Syndrome type 2, and for some reason one cousin and I got dealt the worst. Unfortunately, he passed away in his sleep at 25 in 2012, 2 mo after my Aunt and his mother passed. Long QT can be a sneaky wicked disease!

    Anyway, in 2004, I was one of the first humans to receive the Vitality 2 by Guidant and awoke with news crews in the room. This new device was to last 10 years. Well, it had an issue and depleted after 4.5yrs. My parents were not even made aware until AFTER that I was getting this “new device.” It abruptly started beeping.

    I then got the Teligen E102 in 2009. I know I have natural anxiety after losing family members to this, but I SWEAR it keeps pacing me. I know what it feels like… I’ve had a device for 11 yrs! They keep saying it’s not. I did receive a letter from Boston regarding an “urgent device correction.” They claim the header to be weakened when implanted subpectoral like me… but no one believes me or seems concerned. IS THIS MY ANXIETY IN MY HEAD OR DOES ANYONE ELSE HAVE A SIMILAR SITUATION??? WHAT DO I DO???????

  8. Darrell Reply

    I need a good lawyer. My mom leads miss fire

  9. karen Reply

    shouldn’t Boston Scientific compensate us personally for anything such as lost wages, stress, fear of it will happen again or something else premature happens. What if it starts
    beeping again I had the teligen e110

  10. Robert Reply

    i was also having malfunction problems after having my defibulator installed in 2009 they said I needed new leads once the new leads were put in (end of 2014)it got worse. It was literally trying to kill me I would wake up at night gasping for air, the doctors and people from Boston Scientific repeatly said I was fine, a few months later I was at my therapist office and the defibulator literally exploded in my chest throwing me 25feet across the room and into a wall. They rushed me to the hospital , the doctor said he took out the machine “in pieces.”. obviously there is more detail, pain, suffering and therapy that I had to undergo.

  11. Tammy Reply

    My dad passed away on July 2nd 2016, a little I’ve 1 week ago.
    Primary cause of death was cardiac decompasition.
    He had a Boston scientific internal defibrillator placed 2 years ago…
    He died on July 2nd but the Boston Scientufic unit had not sent a report since June 26th 2016.
    It never triggered and never sent a reading.
    Has anyone else had this issue???

  12. clarence Reply

    Yesterday I took my wife to have her defibrillator checked because in the past week it has beeped at least six times with no shock. In trying to check her defibrillator, the tech got an alert to contact tech support for her defibrillator only to find that there is a defect in the battery. After four years of having this defibrillator there was no issues until now. When we went for her annual checkup the tech told us that the life of the battery was good for another eleven years. Then yesterday ( 4 months) after the annual checkup, there is a problem with the batteries rapidly draining of power. Now, next week we have to go in for surgical consultation to find what options my wife has for this situation. I’m afraid and she is terrified of having to go through this procedure all over again, not knowing if this with make for a better situation with her defibrillator. When the procedure was first done on August 24, 2012 there were complications to where she coded three times during the installation of the defibrillator. In the four years this defibrillator has been in place, it has beeped at least ten times with no shock. Each time we go in for the annual checkup, they say that everything is working fine. Now there is a noticeable defect and this has my wife terrified to the point of her questioning how much longer she has to live. I need someone to talk to as well as represent us if need be.

  13. Rita Reply

    February 2011 my husband had ICD installed. Preoperative chest xrays were perfect.He fell February 2014, and hit his left clavicle directly under the ICD site. All checked out ok, no broken bones, ICD functioning properly. Within 6 months he began experiencing pain under and around the ICD site as well as the left clavicle. He began experiencing frequent bouts of “pneumonia” and was hospitalized numerous times. The pains only intensified. We saw many doctors to try to find and eradicate the problem, all to no avail. He was even sent to a psychiatrist, as his doctors could find nothing wrong with him. Labor Day 2016 I took him yet again to emergency room with another bout of “pneumonia”. ER doctor did yet another chest xray, but this one had a slight shadow peeking out from the edge of the ICD. As it turns out, he had END STAGE METASTATIC LUNG CANCER. The odd thing is it was the size and shape of the ICD, located directly UNDER the ICD, had infiltrated the chest wall and clavicle, and had already metastasized to his brain. He died November 11, 2016. Now, I cannot help but wonder if there was some connection between the device and cancer?

  14. Melissa Reply

    Jan 2005 at the age of 38 I survived 3 sudden cardiac arrests from ventricular fibrillation. I had a Pacemaker Defibrillator implanted. It was on the recall list when implanted but I was told it just needed to be reprogrammed. This was supposed to last 10-11 years but in July 2010 it was replaced for early depletion of battery life. I was never contacted about a recall. Late in 2014 I started to experience strange sensations from my device and in early 2015 a NIPS was preformed, I was told “it is fixed”. Within a few weeks after this procedure was done I was shocked inappropriately. A Lead was suspected to be malfunctioning. In June 2015 my third ICD placement and a new Lead was preformed. The doctors made the decision to only replace one of the two leads due to risk factors and assured me the one left in was fine. I am still experiencing strange sensations from the device but am continuing to be told nothing is showing up on the interrogation report. I live in constant fear of being shocked. I have been shocked more than 11 times which did saved my life but it is a horrifying experience and I just don’t want to be shocked inappropriately.
    What can I do?

  15. Barbara Reply

    I received my icd in Feb 2015. I got my first shock in June, 2015 after getting up to go to the restroom. I thought someone had kicked me in the chest. I called 911 and was hospitalized for a few days. At that time they “adjusted” it. I have been shocked several times since then and all of been appropriate except the last time on November 9th of this year. On that day, they determined that it fired, but there was no reason they could find. I have had severe anxiety ever since my first zap. But now that I realize that it could fire for no reason has increased my fears to the point that I wear a pulse ox meter 24 hours a day to monitor my pulse.. They said it was to go off if my heart rate went to 190. my heart rate on that day in November it was perfectly in the 60’s. What can I do?

  16. Roger Reply

    I had a boston sicentiific pacemaker ICD E110 Guidant Lead 0184/4469 put in May 19 2011 never been Shocked not even once i had this PaceMaker for 6 years if its on Recall dont know never got a letter from no one

  17. Jeff Reply

    My father suffered from some of the problems listed above. His e110 device fired 15 times for an extended period which destroyed his heart and caused his death 4/10/15.

  18. Alison Reply

    i would liketo know when your device leeked or drained early. was defective. Did you have to pay the full cost for replaceing the new device.

  19. william Reply

    I got a aicd and new lead March 2015. Soon after it started like kicking in side.sometimes it last almost day l have complaned many times about it.I was told the New lead could be shut off. After 2 years I had it shut off but it did not stop. The battery naver last 5 years. The day I came home from having implant it started bleeding i spent the night in next day it started beeping lasting 3days until ti was shut off. My doctor tells me this divide don’t look like no other and for some unkown reason cut in to places to do the implant. I ask why no answer and no record. Has any one else had the same problem?

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