Heart patients ponder whether to replace potentially faulty wire
Medtronic’s recent troubles concerning the Sprint Fidelis leads in their heart defibrillators has brought up the question among patients whether they should replace their defibrillators or not. Patients and their doctors are pondering whether they should risk another operation on the off chance that they have one of the potentially faulty wires. To complicate matters, Medtronic has agreed to provide only $800 dollars towards the replacement procedure that could exceed $12,500 dollars and take 90 minutes or more. Up until now, insurers are deciding whether to cover the operation on a case-by-case basis, unless the lead has already fractured. The number of patients with the potentially faulty wires makes this a widespread problem and the recent issue Medtronic has faced has drawn renewed scrutiny to how the medical devices are approved and regulated. In fact, this episode has led to investigations in both houses of Congress. Daniel Schultz, director of the Food and Drug Administration’s center for devices and radiological health concurs, “It seems like a good time to figure out where we are in regulating leads and what we can do better.”
