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.
Janasz noted that Medtronic started alerting physicians worldwide about the potential issue earlier this month and that no patient deaths or serious injuries have yet been reported as a result of the battery short.
A Hong Kong regulatory alert noted earlier this month that 51 local patients received affected ICD models and that the devices are no longer marketed there. Information regarding the device in other countries was not immediately available.
The EnTrust ICDs won FDA pre-market approval in 2005 and Medtronic stopped manufacturing them in April 2011. The Escudo devices were never sold in the U.S.
