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.