Patient Sues Over Defective Heart Lead Wires

The patients are suing for their own damages and as representatives of a class of all users of the device. The lawsuit was filed in federal court in Minnesota, the site of a previous lawsuit against Medtronic for an earlier implantable cardiac defibrillator recall.

The plaintiffs allege that the lead wire portion of the defibrillator is defective due to cracks that develop in the wire. As a result, users of the implanted device may receive jolting shocks when it falsely detects they need a jolt or when the lead wire devices fail to provide defibrillation when the people need it most.

Medtronic announced Oct. 15 that it is halting sales of the Sprint Fidelis line after five people died in which a lead fracture was a likely contributing factor. Medtronic is also not recommending that the lead wires be removed but rather reprogrammed and monitored more by heart specialists. Unused heart lead wires are being recalled.

The FDA considers this a Class I recall. Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Examples of products that could fall into this category are a food found to contain botulism, food with undeclared allergens, label mix-up on a life saving drug, a defective artificial heart valve, or a heart lead wire that fractures.