UPDATE: Medtronic defibs have software bug

May 6, 2010 by MassDevice staff

Six models of Medtronic Inc.'s implantable cardiac devices may have potentially life-threatening defects, according to news reports; no adverse events have been reported and company says the likelihood of any problems occurring is extremely low.

Medtronic Inc. (NYSE:MDT) is notifying health authorities that some of its cardiac devices may contain a software bug.

The Minneapolis, Minn.-based medical device monolith said there are software problems in six models of its implantable defibrillators, according to the reported7thSpace website. The company says the issue may be life-threatening, but the malfunction is rare and no injuries or deaths have resulted from the product defect, according to the website.

As of April 19 this year, the manufacturer has received five confirmed reports of a defect out of approximately 144,000 devices sold, 7thSpace wrote.

The information surfaced when Medtronic International Ltd. notified the Hong Kong Dept. of Health, according to 7thSpace. According to Dr. Westby Fisher, a cardiologist and blogger at NorthShore University HealthSystem in Evanston, Ill., Medtronic is not recommending that patients seek additional action. The problem can be fixed during the patients' next routine checkup. Fisher contacted Medtronic's technical support service and was told that the software issue only becomes a risk "if a rare sequence of events takes place." The company also stated that it's are waiting for Food & Drug Administration approval of a software patch for the problem, according to Fisher.

Medtronic said it identified a risk in select ICD and CRT-D devices and has developed a software patch.

"There is the remote possibility that, due to a rare and specific sequence of events that must occur within milliseconds of each other as one of these devices is charging up, some devices may be unable to deliver therapy when needed," the company said in a prepared statement. "The likelihood of these three specific events occurring within a device is extremely low — at a rate of approximately 0.000037 per year. The probability of these three events occurring while a patient requires life-saving therapy is even more remote, at a rate of 0.0000034 per year."