Medtronic Defibrillator Risk Worse Than Thought


Defective cardiac device leads are in the news again. The Wall Street Journal (WSJ) reports that failure rates for Medtronic Inc.’s fracture-prone defibrillator wires are much higher than what the Minneapolis based company previously divulged. And another finding by UBS Investment Research said that, “lead failures could accelerate over time,” according to Med City News.

Threaded through veins to the heart, lead wires monitor heart rhythm and transmit electric shock if sudden cardiac arrest occurs. But if the device breaks, the implantable cardiac defibrillator (ICD) can discharge a tremendous, painful jolt. Unfortunately, the fractured lead could prevent an ICD from sending that vital shock to the heart. Also, the ICD could send repeated, colossal doses that could too be fatal.

The Sprint Fidelis lead was pulled from the market in October 2007 after death reports involving lead fractures. Medtronic sent doctors a letter alerting them that the faulty wires were a “possible or likely contributing factor” in as many as 13 deaths. Four deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients.

Physicians did complain to Medtronic who apparently remained oblivious to a potentially lethal problem. Instead, they promoted a massive, $100 million ad campaign for ICD products, according to a recently filed lawsuit. Medtronic avowed surgical technique, not defective leads, were to blame. Faulty devices continued to be inserted until Medtronic finally issued a recall following plaintiffs descriptions of ICDs failing at “an alarming rate” worldwide, according to a previous Madison Record disclosure.

Dangerous lead replacement is not advised since the operation could tear blood vessel tissue, the heart, and risk other complications.  Patients with Sprint Fidelis leads were cautioned not to remove the defective components unless they fracture; a dilemma for many nervous patients.

The UBS report declared that “Experience with Fidelis may support tougher regulatory process,” referring to U.S. Food and Drug Administration (FDA) approval for Class III devices via pre-market approval (PMA) supplements, quoted Med City News. Class III devices are considered at the top for risk.

According to the WSJ, Robert G. Hauser and colleagues from the Minneapolis Heart Institute searched the FDA’s database for information regarding extractions of leads for defibrillators and pacemakers. From 1995 through 2008, extractions led to 57 reported deaths and 48 acute cardiovascular injuries, they discovered.