BOSTON SCIENTIFIC IMPLANTABLE DEFIBRILLATOR MAY HAVE CAUSED DEATH

Boston Scientific indicated in a Product Performance Report that its Congnis implantable cardioconverter defibrillator may have contributed to the death of at least one patients. This has raised concerns about Bosth the Cognis and Teligen devices. The company said that the incident occurred with the device’s transformer malfunctioned during the high-voltage charging cycle leading to the loss of telemetry, bradytherapy, tachytherapy and remote follow-up. At least four patients have reported feeling that the device gets suddenly hot at the implant site. The transformer component thought to be the cause of 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. Last month, medical device alters sent out by regulators in the United Kingdom warned of potential battery problems in Medtronic EnTrust defibrillators. The internal debribrillators are implanted near a patient’s heart monitoring the heart rythyms and giving life saving shocks if necessary. Over 233,000 Cognis and Teligen ICD’s have been sold and are in use.