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Boston Scientific Defibrillators May Have Deadly Defect: Report

  • Written by: Irvin Jackson
  • 4 Comments

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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4 comments

  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

    Renee,
    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.

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