Medtronic cease sales of Spirit Fidelis

-Medical & Legal Magazine

10/23/2007- Medical technology firm Medtronic last week suspended all sales of a component used in its implantable devices to treat abnormal heart rhythms – due to fears the defective equipment may have contributed to the death of a number of patients.

The Sprint Fidelis leads link the heart to an implantable cardioverter defibrillator (ICD), which is used to shock a racing heartbeat back to normal rhythm. However, the leads have been found to fracture, causing ‘inappropriate shock and/or loss of output’, which was a possible contributing factor in the deaths of five people.  

Medtronic has advised patients who have been implanted with the ICD not to have the leads removed, due to the possibility of injury during any replacement. These patients are instead told to contact their doctor and have their ICDs reprogrammed, in order to better monitor the lead’s potential to fracture.

Around 268,000 leads have been implanted worldwide. Medtronic is contacting up to 13,000 physicians to advise them on their patients.

Ennis & Ennis, P.A. is representing individuals that have been harmed defective medical devices such as the Medtronic defibrillator and pacemaker. If you or a loved one have suffered as a result of a defective Medtronic pacemaker or defibrillator or if you need more information about the Medtronic recall or class action lawsuit click here for a free, confidential case evaluation.