Medtronic Leads

If you have an implantable defibrillator made by Medtronic, Inc., you should be aware of a serious defect that could threaten your health. Medtronic, Inc. released important information on November 4, 2008, regarding reports of failures of its Sprint Fidelis model 6949 implantable cardioverter defibrillator (ICD) leads.

ICDs are devices that protect patients when life-threatening heart rhythms occur. The defective leads are thin wires that connect the ICD directly to the heart. Based upon Medtronic's own research, these leads, which the company stopped selling in October 2007, have had 42-month failure rates ranging from 3.8% to 6.3%.

Lead failures could cause the defibrillator to deliver an unnecessary shock or to not operate at all. Some deaths and other serious injuries have been reported in cases where a broken lead may have been a possible or likely contributing factor.

Software that can be downloaded into the ICDs has been shown to provide warnings of impending failure up to 3 days in advance. Presumably because of this warning system, Medtronic has not yet issued any public recall or replacement of the devices. Instead,
Medtronic has sent a letter to patients informing them that their physicians have received "updated information" regarding the leads and that "the chance that there will be a problem with your Sprint Fidelis lead remains small."

Earlier, Medtronic, Inc. had recalled more than 80,000 implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) after learning of a battery malfunction that could cause loss of power.

Gemma Law Associates, Inc. is currently investigating injuries and accepting claims involving Medtronic defibrillators and ICD leads. If you believe you may have suffered harm due to one of these Medtronic devices, contact Gemma Law Associates, Inc. at 401-467-2300 or submit an online contact form.

We've been helping clients in Rhode Island for more than 45 years – and we can help you.