Medtronic lead recall applies to defibrillators since 2004, not pacemakers
Following the recent Medtronic lead recall, many individuals with implantable devices have questioned whether they have the potentially dangerous wires. The recall applies to all models of Medtronic Sprint Fidelis leads, which could have been used with any defibrillator implanted since 2004. However, the leads are not used with any types of pacemakers.
>>PRIOR POST (10/18/2007): Medtronic Sprint Fidelis Recall
Medtronic Lead Recall
On October 15, 2007, Medtronic, Inc. announced the recall of all models of their Sprint Fidelis Lead. The small electrical wires could be indicated on the patient information card with any of the following model numbers:
- 6930
- 6931
- 6948
- 6949
Implantable cardioverter defibrillators (ICDs) are one of the main types of devices which could contain the recalled lead. ICDs continuously monitor the heart’s rhythm and issue a lifesaving jolt of electricity if needed to restore a normal beat.
The Medtronic Sprint Fidelis leads are also used with CRT-Ds and complex devices with defibrillation ability. Cardiac resynchronization therapy-defibrillators (CRT-D) are hybrid devices which not only provide a shock, but also provide individuals with congestive heart failure extra pumping power. Other complex devices with defibrillation therapy could include some devices used by individuals with congestive heart failure.
No pacemakers use the Medtronic lead which has been recalled, as a different type of electrical wire is used. Although both pacemakers and defibrillators are implantable devices connected to the heart by a lead or wire, defibrillators are designed to deliver a strong electrical shock to restore the heart to its normal beat when the rhythm is too rapid, and pacemakers are used to detect a heart rate which is too slow (bradycardia). Pacemakers correct this slow heart rhythm by sending electrical signals to stimulate the heart, but this is not strong enough for the patient to feel.
The Medtronics Sprint Fidelis lead was introduced in 2004 as the thinnest available defibrillator lead and many doctors have used it because it is easier to insert into the veins which carry the wire to the heart. While the Fidelis lead has been used with nearly all defibrillators made by Medtronic in recent years, it could also be used with defibrillators manufactured by other companies, such as St. Jude’s, Boston Scientific or Guidant.
To determine if you, a friend or family member may be at risk, consult the patient information card which was provided at the time the device was implanted or contact your doctor. The Medtronic lead recall lawyers at Saiontz & Kirk, P.A. represent individuals nationwide who have one of the defective leads attached to their defibrillator. To review your legal rights or determine if you may qualify for compensation, request a free Medtronic lawsuit consultation.
