Recalled Medtronic Defibrillator, Sprint Fidelis Leads Still Causing Problems
December 28th, 2007 amy
Medtronic recalled its Sprint Fidelis leads in October after five deaths were attributed to the leads fracturing, but the problems and worry are far from over for those still implanted with the leads.
Every few weeks, there’s a news story on someone else whose defibrillator has sent them to the hospital or back to their doctor after they endure one or more severe shocks from their malfunctioning Sprint Fidelis leads.
The Tyler Morning Telegraph reported yesterday on 63-year-old Jerry Jackson, who received six severe shocks to his heart while brushing crumbs off his bed, not an activity most people would consider strenuous enough to prompt a lead fracture. Per the article, his implanted cardiac defibrillator (ICD) had sent 800 volts of electricity into his heart muscle, a jolt doctors compare to being kicked by a horse. Then it happened five more times. The ICD was implanted to shock Jackson when his heartbeat speeds out of control.
Instead, it seemed to be killing him.
Jackson was one of many implanted patients who followed Medtronic’s October warning to visit his doctor to have his defibrillator reprogrammed to prevent such an incident, but the new settings weren’t enough to save Jackson from the shocking experience.
His doctor, Dr. Alex Petrakian of Cardiovascular Associates of East Texas, said Medtronic underestimated the faulty wire’s effect, as he noticed problems much earlier than October, and with more frequency.
Of his 65 patients implanted with a Sprint Fidelis lead, Jackson was the eighth to present with a fracture. “We noticed a problem with that wire before they recalled it, so I stopped using it (in July),”
Petrakian said. “It was unusual that there were reports from all over the country about docs having the same problems.”
Because it’s too dangerous to go in and replace the thin leads, implanted patients are forced to wait and hope that their leads won’t fracture. Since Medtronic is only footing the bill for leads that have fractured, most folks wouldn’t be able to afford to have their leads removed and replaced even if they were willing to risk the surgery.
Medtronic faces multiple lawsuits as a result of its defective leads, both from those already injured and from those whose leads have yet to fracture.
