Medtronic Hasn’t Put Sprint Fidelis Leads Behind It

While the medical device company has already suffered revenue loss, market share, and some confidence of the industry, Medtronic has not seen the end of its Sprint Fidelis defibrillator lead woes. A new report by UBS Investment Research stated that lead failures could accelerate over time. In citing an independent analysis, UBS noted that defibrillator lead failure rates could hit 30% at four years. Medtronic’s numbers suggest a much more modes 3% failure rate at 3 years.
When Medtronic first introduced its newer Sprint Fidelis defibrillator leads, they were praised by the company as the newest breakthrough in medical device technology, far superior to the older Sprint Quattro models. However, the new models have been prone to fracture causing erratic and painful jolts of electricity to the heart. Further exacerbating the problem is the fact that patients who’ve suffered fractured defibrillator leads face the unpleasant choice of having the leads extracted and replaced. There is considerable risk involved in such procedures and at least 3 deaths have been attributed to defibrillator lead extraction.
The Supreme Court has ruled that Medtronic can not be held liable for a device that had previously met the FDA standards. But that may change if Congress passes the Medical Device Safety Act. The bill has received bipartisan support and President Obama has indicated his approval of the measure.