Medtronic Sprint Fidelis Lead Caused PTSD, Lawsuit ClaimsJan 24, 2008 | Parker Waichman LLP
Medtronic has been sued by a man who says a faulty Sprint Fidelis Defibrillator Lead caused him to suffer from Post Traumatic Stress Syndrome (PTSD). Donald LarryJackson claims the unexpected shocks he received from an implantable cardiac defibrillator (ICD) constitute civil battery and caused such severe anxiety he now suffers from PTSD and requires psychiatric care.
A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse via the ICD. When a wire detaches or breaks, the device fails, leaving a patient at risk for death because the device does not sense the need for a shock, is unable to deliver the shock, or delivers an unnecessary shock. Medtronic stopped selling Sprint Fidelis Leads in October 2007 due to a high fracture rate. Fractures of Sprint Fidelis Leads have been implicated in the deaths of five people. It is believed the thin design of Medtronic’s Sprint Fidelis lead wires malfunction due to too-thin diameter models. The Sprint Fidelis Leads’ fracture rate is considered significant.
The Food and Drug Administration (FDA) is investigating the link between defibrillator lead wire diameter and safety and performance issues. The FDA states, "When a defibrillator lead is slightly more prone to fracture, it doesn't mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or 'fractures,' the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered."
Although experts do not advise patients replace leads due to removal risks, which exceed lead failure risk, Jackson underwent emergency surgery to replace the ICD; he continues to suffer heart palpitations, anxiety, and claims to be at increased risk of cardiovascular events or death. Jackson is seeking punitive, exemplary, and compensatory damages, a declaratory judgment, restitution of disgorgement of profits, attorney fees, prejudgment interest, and other equitable relief as requested and is seeking claims of relief for products liability, breach of implied warranty, negligence, intentional infliction of emotional distress, negligent infliction of emotional distress, violation of consumer protection statutes, breach of express warranties, unjust enrichment, battery, and negligent misrepresentation.
Although Medtronic maintains it is advising individual patients, Jackson claims he was not given notice of the increased fracturing risk.