Medtronic Sprint Fidelis Leads Investigated

Washington, DCMedtronic faces two separate investigations involving its [Sprint Fidelis Leads.] The first involves information requested by a Senate panel regarding the Sprint Fidelis Lead recall, while the second investigation, conducted by the US Justice Department, examines allegations that Medtronic made illegal payments to foreign physicians.

According to Medtronic's Securities and Exchange Commission (SEC) filing, the Senate Finance Committee has asked for information about links between the medical-device industry and physicians. Furthermore, the Committee wants information about Medtronic's Sprint Fidelis Lead recall.

Meanwhile, the US attorney's office of the Eastern District of Pennsylvania is requesting information about whether or not Medtronic gave improper payments or gifts to physicians to entice them to use Medtronic stents and cardiac-therapy devices. This is not the first time Medtronic has been questioned for its payment practices. Earlier this year, Medtronic came under fire from Senator Charles Grassley (R-Iowa) who questioned whether or not Medtronic improperly influenced physician's to use its products.

Although the investigations may shed some light onto why Medtronic took so long to initiate its Sprint Fidelis Lead recall, that will not address the concerns of the many patients who already have the leads implanted and are worried that theirs will malfunction next.

Michelle P. (not her real name) wrote to LawyersandSettlements about her concerns regarding her Sprint Fidelis Leads. She writes, "This lead has not fractured yet but the doctors have agreed it is best to remove it now before it fractures because of my history. I am scared and upset that I have to go through another lead replacement with is a very serious surgery." She goes on to note that her Sprint Fidelis Lead had been implanted to replace a different fractured lead and says her doctor informed her that having so many bad leads is like being struck by lightening repeatedly. "I am upset that I have to stop my life again and go through two months of recovery. My ICD is implanted behind my left breast so my recovery time is longer than most."

Other patients have endured very painful shocks when their defibrillator malfunctioned. Danny M. (not his real name) reports experiencing three days of electrical shocks to the left side of his heart. He says that the ICD was removed and the lead was resituated, which was costly, painful and stressful. His Sprint Fidelis Lead was capped off, but he still worries about whether or not his ICD will work when needed. Unfortunately, many patients like Danny M. are left waiting and wondering if their device will work when needed or if they will suffer life-threatening malfunctions.

Medtronic patients are tired of worrying that their devices may not function how they were intended. Many have had to alter their regular activities out of fear that fractured lead wires may affect whether or not they receive a life-saving shock. Medtronic should be held accountable for taking its time announcing a recall, and for any illegal activity the company took part in, if it is proven that improper payments were made to doctors to entice them to use Medtronic products.