Recall of Medtronic Inc. Sprint Fidelis Defibrillator Leads

An implantable cardioverter defibrillator is a life saving device for patients who have heart rhythm abnormalities. The leads connected to the defibrillator have an essential function. They are used to deliver electrical shocks, sense the cardiac rhythm and pace the heart as needed.

On October 17, 2007, the Food and Drug Administration issued a Class I recall on Medtronic, Inc. Sprint Fidelis defibrillator leads. Medtronic Inc. is the largest maker of implantable defibrillators. The reason for the recall is because it has been discovered that these electronic wires are prone to fracture in a small number of patients. These fractures then can cause the defibrillator leads to fire unnecessary shocks or not operate at all.

On October 15, 2007, Medtronic, Inc. made the decision to voluntarily remove its Sprint Fidelis defibrillators from the market. As a result of the Class I recall and the market suspension by Medtronic, Inc., no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to Medtronic, Inc. The models included are 6930, 6931, 6948, and 6949 from September 2004 to October 15, 2007.

Medtronic, Inc. first notified physicians in March of 2007 about the fracture rate and the proper method for implantation. Medtronic, Inc. did note in their statement on October 15, 2007 that following their initial review of reported adverse events, some deaths and major complications had occurred after the leads had fractured.

The recommendation from Medtronic, Inc. is not for surgical removal of the leads. They instead have encouraged practitioners to adjust the defibrillator settings so that the likelihood is greater that a fracture will be detected before a patient is harmed. Medtronic’s statement also included a cautionary note that just because a patient may not have a Medtronic defibrillator, they still may have the Sprint Fidelis leads. The estimated individuals affected by this product defect are between 2,000 and 3,000 patients.

For more information on this recall or to find out how our medical legal consulting services can help you on a case like this, please contact our offices at Medical Jurisprudence, Inc at 1-866-551-4654.

References:
American Heart Association. Implantable Cardioverter Defibrillator. Retrieved from www.americanheart.org.

U.S. Food and Drug Administration. October 15, 2007 FDA Statement: Statement on Medtronic’s Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads. Retrieved from www.fda.gov/bbs/topics/NEWS/2007/NEW01724.html

U.S. Food and Drug Administration. October 17, 2007. Class I Recall: Medtronic, Inc. Sprint Fidelis Defibrillator Leads. Retrieved from http://www.fda.gov/cdrh/recalls/recall-101507.html.