Medtronic Sprint Fidelis recall: Defibrillator lead could fracture

Austin Kirk

By Austin Kirk
Posted October 18, 2007


Medtronic, a global manufacturer of heart devices, suspended sales of their Sprint Fidelis defibrillator lead wire this week.  The leads could be a part of any defibrillator system implanted since 2004.  Defects could cause the wire to fracture or break, resulting in a severe shock or preventing the device from working when it is needed.

>>INFORMATION: Medtronic Sprint Fidelis Recall Lawsuits

Approximately 268,000 Medtronic Sprint Fidelis leads have been implanted in people throughout the world.  According to reports, if the current failure rate of 2.3% continues, approximately 4,000 to 5,000 people could experience a lead fracture during the first 30 months after the device is implanted.

A defibrillator is a small device implanted into the chest of people who are at risk for a cardiac arrest.  If the heart beats improperly, the device delivers an electrical shock designed to restore heartbeat to a normal rhythm.  The Medtronic Sprint Fidelis lead is attached to the defribillator and carries the current from the device through the patient’s veins to the heart. 

Defibrillator leads are very fragile, and the Medtronic Sprint Fidelis which has been recalled is a newer type of lead which is designed to be very thin for easy insertion.  Serious and potentially fatal injuries could be caused by a fractured lead.  Three potential events could occur if the lead fails:

  • Audible Alert: device could make an audible alert of a potential failure
  • Sudden Shock: a severe and painful electrical jolt could be delivered even though it is not needed
  • Battery Depletion: the battery could die, causing a potential failure if the life saving electrical shock is needed to restore the normal heart rhythm.

The Medtronic Sprint Fidelis recall applies to the following model numbers which will appear on the patient card given after the defibrillator is implanted:

  • 6930
  • 6931
  • 6948
  • 6949

Doctors are not recommending the removal of the leads, as risks associated with opening the chest and attempting to replace the wires or add second leads would carry more substantial likelihood for injury than leaving the potentially faulty wires in place.  The FDA and Medtronic have recommended that anyone who has a Medtronic Sprint Fidelis contact their doctors.


The lawyers at Saiontz & Kirk, P.A. are reviewing potential Medtronic Sprint Fidelis lawsuits nationwide for individuals who received a defibrillator since 2004.  To help determine if you, a friend or family member may have the Fidelis lead and if financial compensation may be available, request a free claim evaluation.

4 Comments • Add Your Comments

  • Sarah Allen says:

    I have one of these defective leads implanted.
    Now instead of worrying about my heart stopping unexpectedly I must worry about a shoock from the device that should be protecting me and starting my heart if it stops might possibly shock and STOP my heart.
    This is plainly inexcuseable on the part of Medtronic and the FDA.
    I suppose we are now Medtronics Guinea Pigs!.


    Posted on November 17, 2007 at 12:59 pm

  • gretchen says:

    I had trouble with the 6948 and had to have it explanted three months after it was implanted and also with this 6948 the day I received it I had to be operated on a second time in less than 24 hours because the wires disconnected so I was told I was in worse shape than before so image that trauma and fear! Well Medtronic really topped it off for me when I received another implanted device the 6949 on my right side I receive notice it is on recall and find out that the 6948 is also. If anyone has felt like a guinea pig it is definitely me this device has taken away my ability to be physically active as I was before because the wires are thin that you can’t do any weight lifting or manual upper body execises which are good for the heart I am being deprived of quality of life due to the fact I was always physically active. I even took a job at Kroger as a overnight stocker and they were aware of mydisability so my job was to condition( which is moving all visible products to the front in a neat order) this was nothing but a disaster it was very light duty but using my upper body arms repeatedly caused me to become nauseated and dizzy constantly that I could not perform my task I was trying to get on with my life and work around this faulty defibrillator I feel enslaved to the device it is also a catch twenty-two you are damned either way if you have heart problems and you remove it you could posibly die.

    Posted on May 21, 2009 at 10:20 am

  • Polly says:

    I just had my second surgery due to the frqctured leqd. The first was in Sept 08 where my alarm didn’t alert me my lead was bad and it shocked me 4 times before they could disconnect it. It was. capped and another lead was installed.Then last week I had another surgery to remove the bottom of the same lead that went bad in Sept. My doctor called Medtronic to ask what financial help they’d give me towards my bill and they informed her they would not give me anything. St Jude was willing to help me financiially toward my medical bills and therefore I switched units. I’m so glad to be out of the Medtronic unit.

    Posted on August 4, 2009 at 8:58 pm

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