Medtronic Pacemaker Defects Reported Among Kappa and Sigma Devices
Approximately 37,000 Medtronic Kappa and Sigma pacemakers could contain a wiring defect, according to an advisory letter Medtronic sent to doctors this month. The defect could cause the pacemaker to fail and potentially result in serious injury or death.
At least two fatalities have already been reported that may have been caused by the Medtronic pacemaker defects, which can result in the separation of the wiring between the circuit board and other components. This could cause a loss of rate response, battery depletion, loss of telemetry or no output. Patients who are experiencing problems with the faulty pacemakers may show signs of fanting or lightheadedness.
Out of nearly 1.7 million Kappa and Sigma pacemakers implanted in patients since 1997, Medtronic estimates that less than 2% of the devices contain the wiring defect. The pacemakers were primarily manufactured between November 2000 and November 2002, and many are already approaching the normal elective replacement time.
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Learn MoreDoctors were notified that approximately 15,200 patients implanted with Medtronic Kappa pacemakers and 6,100 patients with Medtronic Sigma pacemakers should be monitored for potential device failures. In addition, another 15,600 patients with Sigma devices that were included in a 2005 advisory involving wire separations caused by a cleaning solvent used during the manufacturing process, may also impacted by this wiring defect.
Despite the potential pacemaker problems, Medtronic has not recommended that physicians consider device replacement unless a patient is pacemaker dependent. If the device is not already at the elective replacement time, Medtronic is offerinig a supplemental device warranty for those patients.
For non-pacemaker dependent patients, physicians have been advised to continue routine follow up and to instruct patients to seek immediate medical attention if they experience symptoms like fainting or lightheadedness.
Medtronic currently faces a number of lawsuits regarding an October 2007 Sprint Fidelis defibrillator lead recall, which involved a faulty electrical wire that connects the defibrillator to the heart. The defective lead was removed from the market because it was found to be prone to fracturing or breaking, which could result in a massive electrical shock or cause the defibrillator to not work when it is needed.
The Heart Rhythm Society has suggested that the FDA and device manufacturers should cease use of the word “recall” in association with implanted heart devices, instead calling the actions advisories or safety noticies. The advocacy group fears that many patients automatically assume that they must undergo surgery to have the defective device removed in its entirety if a recall is issued. However, in many cases, the small chance of a device failure is not great enough to warrant the risk of undergoing a replacement surgery.
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4 Comments
DianeOctober 28, 2009 at 2:58 am
My husband underwent non-cardiac surgery today, 10/27/2009 with a Medtronic Kappa DR 900 series pacemaker in place. It was detected immediately in surgery that there was a Lead fracture. We went through hours of not knowing what to expect and the conclusion of a cardiac physician to see if we needed to do something immediately. We were NOT notified of the recall in June of this year. We were luc[Show More]My husband underwent non-cardiac surgery today, 10/27/2009 with a Medtronic Kappa DR 900 series pacemaker in place. It was detected immediately in surgery that there was a Lead fracture. We went through hours of not knowing what to expect and the conclusion of a cardiac physician to see if we needed to do something immediately. We were NOT notified of the recall in June of this year. We were lucky this time- what about those that were not so lucky????
MarkOctober 24, 2009 at 3:35 pm
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm165711.htm If I am not mistaken this series of pacemakers recalled has between a 3% and 4% failure rate 3.8 years after implantation.
MarkOctober 16, 2009 at 1:52 am
I wish I had the same story to report but unfortunately my sixteen year old son is not here to tell his story so I will. http://www.robertsfight.com
SheilaJuly 14, 2009 at 5:20 pm
I had my first Medronic duel pacemaker placed in 1992, after a total node ablation. Between 2000 - 2002 I received a Medronic Sigma replacement. No problems for a long time. However, recently I have been going into Atrial Fibulation causing palpations, chest pain, and shortness of breath. To-day, is the first time I have heard anything about a 'recall, ' so I am wondering if the pacemaker could b[Show More]I had my first Medronic duel pacemaker placed in 1992, after a total node ablation. Between 2000 - 2002 I received a Medronic Sigma replacement. No problems for a long time. However, recently I have been going into Atrial Fibulation causing palpations, chest pain, and shortness of breath. To-day, is the first time I have heard anything about a 'recall, ' so I am wondering if the pacemaker could be causing my problem? It should be noted that over the seventeen years that I have had a medronic device, I have been delighted with the outcome and it has given me a quality of life more than I could ever have dreamed of before, I recieved my original implant. Cheers to Medronic. . . and I look forward to my next replacement to keep on pacing. . .