The Medtronic Sprint Fidelis Defibrillator
| "These electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured." - Statement by Daniel Schultz, M.D., director of the Center for Devices and Radiological Health |
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The Medtronic Intrinsic (TM) implantable cardioverter-defibrillator (ICD) is seen in this undated handout photo. Sprint Fidelis leads are used to deliver therapy in defibrillators, including ICDs. Medtronic Inc.said on Monday it voluntarily suspended distribution of its Sprint Fidelis family of defibrillation leads, saying the equipment may have contributed to five patient deaths. REUTERS/ Handout/ Medtronic |
| Precautionary replacement isn't recommended because the danger of removal outweighs the risks of a wire failure, Medtronic said. The company already faces more than 900 lawsuits over defibrillators, some of which quit working without warning, customers have claimed. |
What is the Medtronic Sprint Fidelis Defibrillator?
The Sprint Fidelis leads were developed as a thinner, more flexible alternative to the company's older model Sprint Quattro leads.
The Sprint Fidelis leads deliver electrical jolts from stopwatch-sized defibrillators implanted in the chest to regulate a faltering heartbeat. The devices are used in people at risk of cardiac arrest, the biggest killer in the U.S.
| Medtronic suspended sales of the Sprint Fidelis devices globally, saying they may have caused five deaths. The wires, called leads, may break or erode, the Minneapolis-based company said today in a statement. The withdrawal of the leads may hurt sales of the $30,000 defibrillators, especially in Japan. - Bloomberg, October 15th, 2007 |
Why is the Medtronic Sprint Fidelis Defibrillator being recalled?
CHICAGO/NEW YORK (Reuters) - Medtronic Inc said on Monday (October 15th, 2007) it suspended sales of a component used with its implantable devices to treat abnormal heart rhythms, saying the equipment may have contributed to five patient deaths.
Medtronic stopped sales of the Sprint Fidelis line of "leads," the wires that link the heart to an implantable cardioverter defibrillator (ICD), a life-saving device that can shock a racing heartbeat back to normal rhythm.
The company's shares sank 12 percent as analysts predicted the action could hurt what had been a tentative recovery for the struggling ICD industry. Medtronic is the largest maker of the devices, with about 50 percent of the market.
| The company said it identified five patient deaths "in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.'' |
I have a Medtronic Sprint Fidelis Defibrillator. What should I do?
If you experience any unexplained changes to your health or physical symptoms, we encourage you to contact your doctor’s office.
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