Medtronic Sprint Fidelis Leads Shock Man Nearly to Death
November 20th, 2007 amy
Medtronic Sprint Fidelis Leads, recalled but still implanted in many patients’ bodies, may stop working altogether when the wire connecting the defibrillator to the heart detaches. But others are experiencing an equally dangerous problem: multiple shocks. When the wire intended to send shocks to the heart to stimulate heart beat when necessary detaches, it can send unnecessary shocks to the heart which can be dangerous, even deadly.
This is the case for one man implanted with the recalled Medtronic Sprint Fidelis Lead. Thomas Bergstrom received 32 shocks in 40 minutes on June 28, 2007. Sadly, wasn’t even the beginning of his suffering. He was implanted with his first Medtronic defibrillator in February 2004. When his first defibrillator failed, he was implanted with the new Medtronic defibrillator in July 2005, this one with the Sprint Fidelis Lead. In March of 2007, he began receiving his first unnecessary shocks – three in fifteen minutes. He was taken to the hospital but was told the problem couldn’t be with the defibrillator.
Medtronic told him he had nothing to worry about. Instead, he was told the problem was his heart, and he was put on additional medication to slow down his heart.
But by March of 2007, Medtronic was already fully aware that its Sprint Fidelis Leads were malfunctioning. The Minneapolis Heart Institute has already informed Medtronic that their institution would no longer be using the Sprint Fidelis Leads due to multiple complaints from patients who came to them for treatment when their defibrillators malfunctioned. Medtronic and the FDA had already received multiple other complaints but chose to ignore them.
Three weeks after Bergstrom received the 32 shocks in 40 minutes, which almost killed him, he had his defibrillator removed, but he couldn’t have another put in. The leads still remain in his body, and implanting a third defibrillator would require the new one to be in his right shoulder, which is dangerously complicated. Bergstrom has decided he’d rather take his chances with natural death rather than be shocked to death by another potentially defective defibrillator.
