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Defibrillator

Medtronic vet guides Cameron Health

September 1, 2010 by MedCity News

Warren Watson, a 30-year Medtronic Inc. employee with family connections to founder Earl Bakken, is at the helm of Cameron Health Inc. as it looks to develop a leadless defibrillator.

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In mid-May, Cameron Health Inc. struck media gold when the New York Times and the New England Journal of Medicine both gave prominent coverage to the company's efforts to develop the medical device industry's first subcantaneous implantable cardioverter defibrillator.

Not bad for a relatively unknown startup based in San Clemente, Calif.

Zoll wins FDA clearance for device designed for military use

August 2, 2010 by MassDevice staff

ZOLL Medical Corp. receives 510(K) clearance for specially designed Propaq MD Monitor/Defibrillator to be used specifically by the military.

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ZOLL Medical Corp. (NSDQ:ZOLL) is in the army now, having received 510(K) clearance from the U.S. Food & Drug Administration for a Propaq MD Monitor/Defibrillator designed specifically for use by the military.

The announcement comes days after the Billerica, Mass.-based resuscitation products maker announced last week that its military business was down significantly in the third quarter.

Boston Scientific warns on defibrillator problem

July 22, 2010 by MassDevice staff

Magnetic switches in about 34,000 implanted cardiac defibrillators could malfunction, according to a letter Boston Scientific Corp. sent to physicians.

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Boston Scientific Corp. (NYSE:BSX) is warning physicians that some models of its implantable cardiac defibrillators have shown a higher rate of magnetic reed-switch failure, according to the Wall Street Journal.

The Natick, Mass.-based medical device maker said the ICDs, manufactured between January 2006 and November 2007, aren't distributed today. No patient deaths or injuries beyond device replacement have been reported, according to the Journal, which noted that Boston Scientific attributed a rate of one failure per 670 devices to the problem. The probability of harm is estimated to be less than one in one million.

Cardiac Science to replace 24,000 defective defibrillators

July 19, 2010 by MassDevice staff

Cardiac Science Corp. is replacing 24,000 automated external defibrillators that the company couldn't fix with software updates.

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Cardiac Science Corp. (NSDQ:CSCX) will replace 24,000 automated external defibrillators implicated in a November 2009 recall.

The Bothell, Wash.-based company's Powerheart, CardioVive, Nihon Kohden and GE Responder AEDs have electrical component flaws that may cause device failures. The flaws could not be remedied through software patches, according to the Food & Drug Administration.

Boston Scientific commences Cognis multi-sensor clinical trial

July 8, 2010 by MassDevice staff

Boston Scientific Corp. enrolls the first patient in its MultiSense clinical trial of multiple sensors used with its Cognis cardiac resynchronization therapy defibrillator.

BSX logo

Boston Scientific Corp. (NYSE:BSX) is looking to get back on its feet after a series of mis-steps for its cardiac defibrillator operations.

The Natick, Mass.-based medical device maker enrolled the first patient in its MultiSense clinical trial, aimed at evaluating the use of multiple sensors with its Cognis cardiac resynchronization therapy defibrillators.

FDA: Class I recall for Medtronic's Physio-Control defibs

July 7, 2010 by MassDevice staff

Medtronic Inc. subsidiary Physio-Control's "field correction" for its LifePak 20/20e defibrillators is now a Class I recall, according to the Food & Drug Administration.

MDT Physio-Control logo

The Food & Drug Administration slapped Medtronic Inc. (NYSE:MDT) 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.

Class I recalls mean the federal watchdog agency believes a product could cause serious injury or death.

More defib trouble for Medtronic's Physio-Control division

July 2, 2010 by MassDevice staff

Physio-Control Inc., the Medtronic Inc. defibrillator subsidiary, issues a "field correction" aimed at battery problems with its LifePak 20/20e device.

MDT Physio-Control logo

Medtronic Inc.'s (NYSE:MDT) headache over its Physio-Control Inc. subsidiary is turning into a veritable migraine, as it reveals another issue with its LifePak line of defibrillators.

Redmond, Wash.-based Physio-Control said it issued a "field correction" for some of its LifePak 20/20e defibrillators, after discovering that some of the devices might lose battery power while in operation.

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