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Medtronic Defibrillator Lead

Device name: Sprint Fidelis Defibrillator Lead
Manufacturer: Medtronic
Approved uses: Approved for use in a defibrillator system with a device implanted near the shoulder and one or more leads, or wires, connecting the device to the heart for the purpose of defibrillation in the event of cardiac arrest in those at risk.
Malfunctions:
  • There is a small chance of fractures in particular locations on the Sprint Fidelis lead, which can cause the device to either deliver an unnecessary electrical jolt or fail to provide a life-saving one to a patient in need.
Related topics: Medtronic Defibrillator
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Sprint Fidelis Defibrilator Lead

On October 15, 2007 Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected in a number of patients. This voluntary defibrillator lead recall came after Medtronic identified five patients whose deaths may have been related to a fractured Sprint Fidelis defibrillator lead. As a result of Medtronic's action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company, according to the Food and Drug Administration (FDA). While the FDA has not suggested or mandated the Sprint Fidelis lead me removed from the more than 268,000 patients who are implanted with the lead, those patients are encouraged to contact their physicians for further information.

Medtronic Sprint Fidelis Defibrillator Lead Recall Could Effect Hundreds of Thousands

On October 15, medical device maker Medtronic announced a safety recall of a type of wire used in its implantable defibrillators, called Sprint Fidelis defibrillator leads. The Sprint Fidelis defibrillator lead is the part that sends the shock from the device to the heart. Unfortunately, the company said, its Sprint Fidelis defibrillator leads break more often than they should, which can lead to sudden and painful shocks at times when nothing is wrong -- or no shock at all when it’s needed to save a life. read more

Important Facts Regarding Implanted Defibrillators

Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used in patients whose hearts beat too fast and out of rhythm. Healthy hearts beat at the pace of 50 to 100 beats per minute, depending on the person’s exertion level, drug and caffeine intake and general health. ICDs and CRT-Ds consist of two parts: A small computerized device, generally implanted in the shoulder, and a lead, or wire, that runs through the patient’s own veins to the heart itself, where it’s secured with screws. read more

View the Medtronic Defibrillator Lead Law Articles page here

Medtronic Defibrillator Lead News Articles

No. There currently is too much scrutiny against US medical devices - GLG News

Medtronic Bone Product Faces Pressure From U.S. - NYTimes.com

View the Medtronic Defibrillator Lead News Articles page here

Medtronic Defibrillator Lead Newsfeeds

Texas Law Firm Files Multiple Suits Against Medtronic as Deadline Approaches

Medtronic to report patient death to FDA: report

View the Medtronic Defibrillator Lead Newsfeeds page here

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