Storms is just one of many individuals who were injured when the Sprint Fidelis leads attached to a defibrillator fractured and malfunctioned. Medtronic voluntarily suspended distribution of the Sprint Fidelis Leads in 2007, the same year Storms’ defibrillator shocked him, after receiving reports of numerous intentional shocks and five deaths related to the faulty leads. Medtronic has since upped the number of deaths linked to the malfunctioning defibrillator leads to 13.

Cardiac defibrillators are placed in patients with life threatening heart conditions to help detect and correct irregular or rapid heart rates. Lead wires attached to the defibrillators and placed in the heart give shocks to correct irregularities detected by the defibrillator. In some individuals with Medtronic devices, the Sprint Fidelis leads have fractured or broken, causing the lead to inappropriately shock the patient or not fire at all.

Following the recall, patients like Storms who were harmed by their devices, began filing lawsuits against Medtronic only to have them thrown out by a judge citing a 2008 Supreme Court precedent that argued that devices that have been approved by the FDA were immune from state tort suits. But all that could change if lawmakers pass the Medical Device Safety Act. The legislation would restore the rights of patients who have been harmed by unsafe medical devices to seek justice in state courts.

Source: Cleveland.com

SOURCE: Sprint Fidelis Lead Recall › Man says faulty defibrillator felt like being kicked by horse