British regulators issue a safety alert on a battery defect in Medtronic EnTrust defibrillators over concerns that a short circuit could leave patients without pacing.
British regulators issued a safety warning on Medtronic's (NYSE:MDT) EnTrust implantable cardioverter defibrillators over concerns that some of the devices may have a defect that could cause the batteries to deplete prematurely.
U.K. authorities recommended that patients with the affected devices check with their doctors and reprogram their devices to beep in case of low battery, Reuters reported.
The Minneapolis, Minn.-based med-tech giant issued an alert earlier this month on its EnTrust and and Escudo ICDs, warning that less than 1% of the global distribution of the devices may be susceptible to an internal short circuit that could drain the device battery without providing adequate warning.
"Typically, these heart devices have 3 months of normal operation after the device signals the need for replacement," Medtronic spokeswoman Kathleen Janasz told MassDevice in an email. "EnTrust devices may require replacement sooner than expected, and result in less than 3 months of normal operation once the device indicates the need for replacement."
About 69,000 patients have received the EnTrust device, according to the news service.
Edwards Lifesciences CEO Michael Mussallem says the company now expects the FDA to approve its next-...
Reva Medical begins enrolling patients in Europe for a trial of its Fantom bioresorbable stent.
A subcommittee of the U.S. Senate's powerful Finance Committee holds a hearing on the medical device...
Zimmer Holdings and Biomet find a buyer for the knee and elbow assets they pledged to divest to...