The FDA has issued a Class I Recall of Medtronic Sprint Fidelis defibrillator leads due to fracture risk that can result in unwarranted shocks being applied to the implanted patient’s heart. In the case of this recall, it seems that physicians at the Minnesota Heart Institute made the company aware of possible problem back in February, when for two days in a row they had patients claim that they received shocks from their defibrillators at times when they shouldn’t have. This caused some alarm and was reported to Medtronic. One of the physicians apparently did his own review of the leads and repeatedly over the next months called for their removal from the market.
It was reported in a Minnesota paper that several area cardiologists had stopped using the leads due to concern of fracture possibility. Medtronic did conduct their own analysis of the leads covering almost 25,000 patients concluding that leads had a 2.3 percent failure rate over the 30 months that they had been on the market. This is over twice as high as another model by Medtronic, the Quattro, which was determined to have a failure rate of less than one percent.
Medtronic claims that they did not hide anything and when they were sure of a problem took immediate and appropriate action. Medtronic claims that they could not simply pull the product from the market after receiving reports from an individual hospital and needed to perform its own research to determine if there was a problem. Finally in October the Medtronic reached the same conclusion suspended sales of the Sprint Fidelis leads. A Class I Recall soon followed.
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.