Future faults possible in the Medtronic defibrillators
Deutsche Bank released a research report concerning additional problems on the horizon with the Sprint Fidelis lead wires used in the Medtronic defibrillator devices. Deutsche Bank analyst Tao Levy said in the report that while the impact of the recall was not as severe as anticipated, more distressing news may still be on the horizon. Nevertheless, the lead fractures could continue to require more replacements. Levy said the Fidelis lead may also offer poor sensing capabilities, ultimately leading to inappropriate shocks. "This latter concern is something new we have learned from our clinician contacts, and we could see published in medical journals," he noted in the report. "Bottom line is that while Medtronic has done a good job in managing the Fidelis recall, there will be clinicians who are not only frustrated with the number of leads affected but also by the increasingly poor performance of the lead," Levy wrote. The analyst said this could result in permanent loss of market share in implantable cardioverter defibrillators. A spokesperson for Medtronic said that the company is aware of the report but doesn't have immediate comment. In October, the medical-device maker suspended its Fidelis family of defibrillation leads because of the potential for the wires to fracture. Regardless, the company gave a report on the progress of the lead recall, which resulted in a meager 2% decline in earnings.
