Medtronic Battery Short
On February 11, 2005, Medtronic Inc. announced it was issuing a notification to physicians about a potential electrical short in the batteries of certain models of the company's implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D) devices. Seventy-five percent of the affected Medtronic battery short models were implanted in the United States.
Battery Short Leading to Battery Depletion
According to the company, the Medtronic battery short could occur in a subset of ICD and CRT-D models. Battery shorting can lead to battery depletion and loss of device function within hours or a few days. The warning notification said affected Medtronic defibrillators included devices manufactured between April 2001 and December 2003 in subsets of:
- the Marquis VR/DR
- Maximo VR/DR ICD models
- InSync I/II/III Marquis and
- InSync III Protect CRT-D devices.
The rate of Medtronic battery shorts in affected models, according to the company, is extremely low. At the time of the safety warning, the company had reports of nine batteries experiencing rapid battery depletion because of Medtronic battery shorts. Of the nine Medtronic battery short incidents identified, physicians discovered six of the cases during patient visits.
Risk of Battery Shorts
Medtronic began notifying physicians about the risks of battery shorts on February 10, 2005, providing them with a list of potentially affected patients and recommending they speak with them about the safety concerns. Battery problems date back to 2003 when the company detected a battery malfunction in certain device models during internal quality testing. After identifying the electrical shorting mechanism and making modifications to correct it, the FDA approved the redesign.
In the spring of 2004, problems for patients who had received devices containing the defective batteries first began to emerge when a failed ICD that had been removed from a patient was returned to the company for analysis. After the Medtronic battery short warnings were issued, patients potentially affected by the defective devices criticized the company for continuing to market and sell existing inventory of ICDs and CRT-Ds and failing to disclose the problems to medical professionals, patients and regulatory authorities until much later. The FDA has also been criticized for over-relying on the industry to police itself despite the life saving importance the devices have.
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