Medtronic Inc. (NYSE:MDT) announced that it has stopped distribution of Sprint Fidelis leads due to a fracture that may have been a contributing factor in the death of five patients.
A defibrillation system is a device that is implanted near the shoulder with one or more leads connecting the device to the heart. The device monitors the patient's heart and if it senses an abnormal rhythm, it sends an electronic shock to reset the heart to a normal beat.
“There is nothing more important to us than the safety and well-being of patients,” said Bill Hawkins, president and chief executive officer of Medtronic. “We take all matters of product quality very seriously and believe this action is the right thing to do given currently available information.”
Indication of a fracture may be an audible alert, inappropriate shocks and/or loss of output.
Medtronics is recommending that patients with the Sprint Fidelis (models: 6930, 6931, 6948,6949) contact their doctors, have offered up a toll free number for more: 1-800-551-5544 ext 41835 and have set up a web site for more information.
Patients with a Medtronics pacemaker are not affected by this problem.
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