Medtronic Class Action Lawsuit
Medtronic Inc. issued an alert to doctors on February 10, 2005, regarding its product line of Implantable Cardioverter Defibrillators (ICD) and CRT-D devices with batteries that were manufactured before December 2003. The ICD is a pacemaker-like device that is surgically implanted in patients who suffer from irregular heartbeat. Unfortunately, it has been found that some of the units may contain a faulty battery mechanism which can result in a rapid loss of battery power after which the device will not operate properly, if at all.
Specifically, the problem is with the “leads” that run from the device to the heart and deliver a “shock”
to the heart when an abnormal beat is detected. The “Sprint Fidelis” leads may fracture resulting in either shocks to the heart when none are needed or a failure to shock when an abnormal beat occurs. To date, five deaths have been attributed to this defect and 599 reports of malfunctions had been given to the FDA by January 2007.
Medtronic has agreed to replace the device which costs about $20,000 as well as pay for some expenses but has not agreed to pay for the replacement surgery itself. Roughly 13,000 have already been surgically removed from patients.
The following devices, manufactured between April 2001 and December 2003, were affected:
- Marquis VR/DR
- Maximo VR/DR ICDs
- InSync I/II/III Marquis
- InSync III Protect CRT-D
Model numbers that appear alone or begin with 6949, 6948, 6931 and 6930 are suspect.
Medtronic’s Micro Jewell II and GEM DR ICDs were also recalled in 2004.
Professionals in the medical field have advised that if you have one of Medtronic’s defibrillators implanted you consult with your physician as soon as possible to discuss your options.