
Medtronic released warnings that a limited number of its EnTrust and Escudo implantable cardioverter defibrillators may have an internal short that may cause the device batteries to deplete prematurely.
The issue affects a small number of implants, less than 0.1% of the global distribution, Medtronic spokeswoman Kathleen Janasz told MassDevice in an email.
"Typically, these heart devices have 3 months of normal operation after the device signals the need for replacement," Janasz wrote. "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."
A Hong Kong regulatory alert noted 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.
Janasz noted that Medtronic started alerting physicians worldwide about the potential issue week and that no patient deaths or serious injuries have yet been reported as a result of the battery short.
Patients with affected ICDs should continue regular check-ups, Medtronic advised, and physicians may program the devices to beep when they need to be replaced.
Affected EnTrust model numbers affected are D153DRG, D153VRC, D153ATG, D154VRC, D154DRG and D154ATG, and Escudo D144DRG and D144VRC.