Medtronic, the largest provider of heart implant devices, announced that it was stopping sale of a component of one of it defibrillator models because of a defect that had caused defibrillator malfunctions in hundreds of patients and possibly had led to five deaths.
The faulty component in the defibrillator can cause the device to deliver a shock at the wrong time. It can also fail to deliver an electric shock to the heart at the time when the heart needs it most. The faulty component is known as the Sprint fidelis, or lead, and Medtronic is urging all 235,000 patients with defibrillators to see their doctors to make sure they do not need surgery to replace the lead. According to Medtronic, approximately 2.3% of patients with the defibrillators – 4,000 to 5,000 people – will need the surgery.
According to reports, the Fidelis lead has been in use with Medtronic defibrillators since 2004, and most patients who received Medtronic defibrillator since then have them.
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.