Lead Malfunctions Halt Medtronic ICD Product Sales
Recent data implicates the Sprint Fidelis defibrillation leads used in Medtronic implantable cardiac defibrillators (ICDs) in the death of five patients, though the primary cause of deaths remains to be clarified. As a result, Medtronic opted to suspend sales of the ICDs, as reported by Reuters.
The Sprint Fidelis models 6930, 6931, 6948, and 6949 appear to have a minimal opportunity for fractures within particular locations of the leads. Medtronic is recommending that implantation of the devices cease and that all unused defibrillators be returned to the company. It is estimated that less then one percent of the leads may have the fractures noted.
At this time, the company is not requesting that devices which have already been implanted be removed, citing concerns about complications which may result during removal. Instead, patients are requested to be vigilant, monitoring the device for the occurrence of unnecessary shocks or audible alerts.
The problem with the fractured leads is that these can interfere with the correct operation of the defibrillation device, including delivery of shocks that are not required or a complete failure of the device.
Defibrillators are used to monitor patient heartbeat. When abnormal rhythms occur, the device delivers a slight electrical pulse to return the heart to its normal rhythm. A defibrillator is often implanted near the shoulder and then leads are directly connected to the heart.
October 15, 2007 Related topics: Product Recalls, Monitoring, Quality, Safety, Errors, Cardiology