Defective Defibrillator Wires Associated with Patients Death
by Sandra Cassidy
On October 15, 2007, medical device maker Medtronic announced a safety recall of defective wire leads in the Sprint Fidelis defibrillator after a number of fractures in the wire were causing patients to receive electrical shocks. According to Dr. William Maisel, reporting in the Los Angeles Times,the shock is comparable to being kicked by a horse or struck by lightening. A patient subjected to a defective wire can experience this 30 or more times an hour. The defect has been associated with the deaths of 5 patients.
The New York Times reported that Medtronic initially began considering a recall in September after 30 months of data showed a continuous problem with lead breaks. But the recall was not announced for nearly three months and after the defect was associated with the deaths of 5 patients. Dr. Sidney Wolfe, director of the health research group at Public Citizen wrote in a letter to the FDA that Medtronic waited too long to initiate the recall. Dr. Wolfe pointed to data which showed a 400% increase in reported injuries over the first 10 months of 2006. Medtronic has confirmed 665 fractures in leads that have been recalled.
Young patients seem to be at a higher risk for wire breaks because they put a greater stress on the device. According to the Wall Street Journal researchers have found a 6.7% failure rate among young patients. The manufacturer found a 3.8% failure rate for one model of the Sprint Fidelis defibrillator. It is estimated that since 2004 268,000 people worldwide have had this device implanted. Of these 2.3% can expect the Sprint Fidelis defibrillator lead to break within 30 months implant. Medtronic currently estimates that 4 to 5 thousand patients may need expensive risky surgery to replace the leads, surgery that carries the risk of major complications including arterial damage as body tissue tends to grow around the wire leads.
The Sprint Fidelis leads are used with Implantable Cardiovascular Defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds). ICDs and CRT-Ds are used in patients whose hearts beat too fast and out of rhythm. ICDs and CRT-Ds consist of two parts: a small computerized device generally implanted in the shoulder, and a lead, or wire that runs through the patient’s veins to the heart where it is secured with screws. The computer monitors the heart beats, sending out shocks when the beat is irregular.
The Minneapolis Heart institute seemed to know where this was headed even before the recall, as they discontinued use of the Sprint Fidelis leads in February. The FDA and Medtronic state that the recall does not mean all patients with the Sprint Fidelis Defibrillator leads should have their leads replaced. Both the FDA and Medtronic recommend contacting your doctor and adjusting the settings on the defibrillator. Doctors should weight the risks associated with continuing use of the leads or capping the lead so it is no longer useable and implanting a different model. The FDA warns patients that a small number of Sprint Fidelis leads are used with defibrillators made by other manufacturers, so all patients should contact their doctors to check.
This is not the first recall caused by faulty wires for Medtronic. In November 2005, the company recalled its Sigma Series pacemakers because of wiring problems that made the devices useless and unable to do their jobs. The defects affected 40,000 pacemakers worldwide. There are four model numbers implicated by the Sprint Fidelis recall they are 6930, 6931, 6948 and 6949.
Lawsuits have already been filed in the US and Canada over these defective leads.
Sources
Medtronic Recalls Defibrillation Leads
Medtronic-defibrillator lead
Los Angeles Times cardiologist and FDA consultant Dr. William Maisel
citizen.org Letter to the FDA October 16 2007
Recall of defective medtronic Sprint Fidelis Defibrillator leads
DrugInjurywatch.com
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