Cardiac Defibrillator Maker Medtronic Recall
Medtronic Sprint Fidelis & Other Defibrillator Models Recall Lawsuit Information & Consultation
Recall of Sprint Fidelis Cardiac Leads
Medtronic Inc. has stopped distributing Sprint Fidelis defibrillation leads because of the possibility that these leads could fracture in a small percentage of patients.
Although the leads continue to function properly in the vast majority of patients, if one does fracture, the defibrillator could deliver unnecessary shocks or not operate at all. Some deaths and major complications have occurred when the leads fractured.
The affected products are Sprint Fidelis Models 6930, 6931, 6948, and 6949. They are used with implantable cardioverter-defibrillators (ICD) or cardiac resynchronization therapy defibrillators (CRT-D).
Medtronic is advising physicians to stop implanting the leads and to return unused leads to the company. FDA and Medtronic are not recommending prophylactic removal of the leads in most patients, because the risk of removing the lead exceeds the small risk of a fracture.
In addition, the company recommends reprogramming the device to monitor the patient more effectively for potential problems, and to provide an audible alert if a lead does fracture.
Patients who have the Sprint Fidelis lead should contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations. Patients should also recognize that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic. If patients think they have a Sprint Fidelis lead, or if they do not know the model of their lead, they should contact their doctor.
source: fda.gov
Medtronic Sprint Fidelis Defibrillator Leads
Food & Drug Administration Latest Update:
 [UPDATED 10/17/2007] FDA issued a Class I Recall of Medtronic Inc. Sprint Fidelis Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007. Patients who are implanted with this lead, or do not know the model of their lead, should contact their physicians for further information.
[Posted 10/16/2007] FDA issued a statement announcing Medtronic's decision to voluntarily suspend distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. 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.
When a defibrillator lead is slightly more prone to fracture, most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.
Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. Patients who are implanted with this lead are encouraged to contact their physicians for further information.
[October 17, 2007 - Recall Notice - FDA]
[October 15, 2007 - FDA Statement - FDA]
[October 15, 2007 - Consumer Q&As - FDA]
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