Patient sues Medtronic over painful lead shocks

02/04/08

Donald Jackson received a defibrillator implantation in 2006 that included a lead wire manufactured by Medtronic, Inc. The lead, known as the Sprint Fidelis, was voluntarily recalled by Medtronic in late 2007 amid reports of unnecessary and repeated shocks to patients as a result of fractures to these leads.

Jackson has sued Medtronic, claiming he suffered excruciating pain when he was subjected to unnecessary shocks, and now requires psychiatric treatment to deal with the ongoing stress of his predicament.

Defibrillators are intended to administer electric shocks to a patient’s heart in order to regulate an abnormal heartbeat. Lead wires implanted directly in the heart muscle connect to the defibrillator unit, sending information to the unit about the patient’s heart rhythm. A break or “fracture” in the wire results in mixed electrical signals being sent to the defibrillator that may cause unnecessary painful shocks to the patient. Sprint Fidelis leads were recalled after Medtronic acknowledged that the leads have a higher failure rate than that of their predecessor product, the Sprint Quattro lead.

In the current lawsuit – one of many such suits filed across the country – Jackson claims his Sprint Fidelis lead is defective and has caused much “physical, emotional, and psychological suffering and extreme anxiety.” Jackson has been prescribed medications to deal with his anxiety, but claims he still has an “imminent apprehension of death.” The suit also alleges that “as a result of problems with the lead, [Jackson] has an increased risk of death or major heart problems.”

Jackson seeks punitive damages from Medtronic on the basis that the company acted in an “intentional, reckless, and grossly negligent” manner in the manufacture and marketing of the Sprint Fidelis lead. Suit was filed on January 18, 2008, in U.S. District Court.

Source: “Lead Shocks Send Patient to Psychiatrist, Courtroom.” Fdanews.com, February 4, 2008.

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