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Medtronic Recall

 

Defibrillator Leads May Fracture, Risking Serious Injury or Death

medtronic sprint fidelis lead

October 15, 2007—Medtronic announced a recall of its Sprint Fidelis defibrillator leads after numerous reports of device failures leading to serious injuries and at least five deaths. An estimated 235,000 people have been implanted with the Medtronic Sprint Fidelis leads.

Leads are used to link a defibrillator or pacemaker to the patient's heart. Medtronic reports that the device can fracture after implantation, delivering a painful and potentially deadly electrical jolt to the patient.

Medtronic estimates that 2.3% of patients with these affected leads will experience failure within 30 months of implantation. Those people whose devices fail face a risk surgical procedure to remove the defective leads. Most patients who received Medtronic defibrillators since 2004 have the defective Sprint Fidelis leads.

Patients with Medtronic defibrillators should refer to their Patient ID card to determine whether the leads for their device are affected by the recall. The recall includes the following models:

  • Model 6930
  • Model 6931
  • Model 6948
  • Model 6949
 

Sprint Fidelis Leads Used Often With Medtronic Defibrillators Implanted Since 2004

medtronic lead recall

The problems with the Sprint Fidelis leads reportedly were brought to the company's attention in early 2007 by Dr. Roger G. Hauser of the Minneapolis Heart Institute. Dr. Hauser played a critical role in uncovering problems related to defibrillators manufactured by Guidant.

Medtronic officials told Dr. Hauser there was not enough information to reach any conclusions about the safety of the leads. It later warned doctors in a March 2007 letter of potential problems with the devices. Medtronic waited until October 2007, however, to issue a recall of the defective leads.

Medtronic has said it will not pay for procedures to replace the leads, and only would pay $800 to those patients whose devices failed and require surgical removal.

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