Medtronic Sprint Fidelis Defibrillator Lead Could Have Sensing Capability ProblemsNov 27, 2007 | Parker Waichman LLP
Medtronic Sprint Fidelis Defibrillator Lead wires could have even more problems than once thought. While the Sprint Fidelis Leads where recalled by Medtronic in October because of a higher-than-normal fracture rate, there is now concern that the leads could also have poor sensing capabilities. This defect could cause a Medtronic defibrillator to deliver inappropriate shocks to the heart.
Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient’s heart rhythm is out of sync. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.
The Sprint Fidelis Lead was designed to replace Medtronic’s Sprint Quattro models, and it is one of the thinnest defibrillator lead wires on the market. Since it was introduced in 2004, Sprint Fidelis Leads have been implanted with 90% of Medtronic’s defibrillators. But within a couple of years of the Sprint Fidelis Lead’s introduction, emergency rooms around the country began to see patients injured by the fractured device. A data analysis performed by the Minneapolis Heart found that the thinner Sprint Fidelis lead had a higher chance of fracturing than the Sprint Quattro. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the FDA that the defective Sprint Fidelis Lead was “significantly less reliable” than its predecessor.
But lead fractures might be only one of the Sprint Fidelis’ problems. According to a the website TheStreet.com, a report by a Deutsche Bank analyst regarding the impact of the Sprint Fidelis Lead wire recall on Medtronic’s bottom line said that more bad news could be on the way. The analyst wrote that there had been reports that the Sprint Fidelis Lead wires had poor sensing capability. The Deutsche Bank report said that concerns over the Sprint Fidelis Defibrillator Lead wires sensing capabilities “is something we have learned from our clinicians contacts, and we could see published in medical journals.”
The Sprint Fidelis Defibrillator Lead recall has hurt Medtronic’s bottom line. Earlier this week, the company said that revenue in its Cardiac Rhythm Disease Management unit was down by $130 million, and it also absorbed $31 million in costs to write off the Sprint Fidelis leads recalled during the quarter. Last month, Medtronic had predicted a $150 million to $250 million loss of second-quarter revenue and inventory write-off costs of $15 million to $20 million. The Deutsche Bank report also speculated that further problems with the Sprint Fidelis Lead wire could weigh even more heavily on Medtronic’s finances. The analyst wrote that the Sprint Fidelis problems could result in permanent loss of market share in implantable defibrillators to other company’s such as St. Jude Medical and Boston Scientific.