Lead Shocks Send Patient to Psychiatrist, Courtroom

-FDA News

02/04/2008 - A patient affected by Medtronic’s 2007 recall of defibrillator leads is suing the company, claiming unnecessary shocks led to post-traumatic stress syndrome that required psychiatric treatment.

Plaintiff Donald Jackson received an implantable cardioverter defibrillator containing a Sprint Fidelis lead in 2006, which he says gave him unexpected and medically unnecessary shocks, causing excruciating pain.

The shocks caused “great physical, emotional and psychological suffering and extreme anxiety,” placing Jackson in “imminent apprehension of death,” the complaint says. It adds that Jackson is now prescribed mood-stabilizing drugs. And, as a result of problems with the lead, he has an increased risk of death or major heart problems.

The complaint, filed Jan. 18 in the U.S. District Court in the Eastern District of Texas, alleges Medtronic misrepresented the safety of the leads and negligently manufactured, marketed and sold the leads as safe, effective devices. Because such acts were “intentional, reckless and grossly negligent,” the plaintiff is seeking punitive damages.

If you or a loved one have had the device replaced or plan to have it replaced you may be entitled to compensation regardless if you suffered as a result of complications from surgery or the device itself. Contact the Medtronic attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding the Medtronic pacemaker defects, a possible Medtronic class action lawsuit, or any other type of Medtronic Pacemaker litigation.