Summary

Original source:
http://today.reuters.co.uk/News/newsArticle.aspx?type=healthNews&storyID=2005-02-11T195110Z_01_N11525845_RTRIDST_0_HEALTH-HEALTH-MEDTRONIC-DC.XML

Details

• Medical device maker Medtronic Inc. said on Friday it has begun warning doctors about some faulty batteries installed in a line of its implantable heart defibrillators.
• The problem involves batteries in its Marquis line of implantable cardioverter defibrillators (ICDs) made before December 2003, Marshall Stanton, medical director of Medtronic's cardiac rhythm management unit, told Reuters.
• Stanton said the battery problems occurred in nine patients out of 87,000 worldwide.
• He said Medtronic would send letters detailing the problem to physicians who have implanted the devices.
• ICD batteries typically last for several years.
• Stanton said the problem does not involve Medtronic's Intrinsic and Sentry ICD lines, or any Marquis ICD made after December 2003.
• For patients using an ICD primarily for its pacemaker functions, the device will need to be replaced in a procedure requiring no more than 45 minutes, according to Alan Kadish, a cardiologist at Northwestern Memorial University in Chicago.
• These are patients who need the device to keep every single heartbeat on track, as opposed to those who need it for an occasional irregular heartbeat, he said.
• Medtronic, which makes its own ICD batteries, discovered the potential for rapid battery depletion during lab testing.
• The company changed to a new battery design in December 2003.
• "The only substantial risk here is the risk of infection" when opening the patient up, Kadish said.
• I don't think it will harm anybody physically, but it is making for a lot of work," said Silver, who has 39 patients with the Marquis devices.
• Earlier on Friday, JP Morgan analyst Michael Weinstein said in an analyst note the company had begun calling doctors to warn of the problem, but characterized the letter as a "nonevent."

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