Medtronic Fixing Defibrillator For Battery Issue

MedtronicMedtronic Inc.’s Physio-Control subsidiary said that it has launched a field correction effort to fix certain devices used to shock patients in cardiac arrest because it found a potential battery-power problem, and that one patient may have died as a result. The FDA said nearly 43,000 Lifepak 20 and Lifepak 20e defibrillator/monitors are at issue worldwide.

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FDA Issues Class I Recall for Physio-Control’s LifePak 20/20e Defibrillators

The Food & Drug Administration has slapped Medtronic Inc’s subsidiary Physio-Control Inc. with a Class I recall of its LifePak 20/20e defibrillators after the company declared a “field correction” for a battery problem last week. Physio-Control issued a “field correction” on July 2, after discovering that some of the devices might lose battery power while in operation.

Europe initiates implants of Cognis, Teligen

Boston Scientific LogoBoston Scientific Corp. has announced the commencement of the use of its Cognis cardiac resynchronization therapy defibrillator (CRT-D) and Teligen implantable cardioverter defibrillator (TM-ICD) by European doctors. Both these cardiac rhythm management devices received the CE Mark approval in January and are awaiting approval in the US. These are among the smallest and thinnest high-energy devices in the world and offer improved battery life and self-rectifying software.