Medtronic issues urgent field safety notice for select ICDs, CRTds

Medtronic (NYSE:MDT) issued an urgent field safety notice concerning issues with specific units of its Viva cardiac resynchronization therapy defibrillators and Evera implantable cardioverter defibrillators that could result in rapid battery depletion. The Fridley, Minn.-based company sent the notice on August 12 to healthcare professionals managing patients with the devices. The notice warned of issues with 78 specific Viva CTR-D and Evera ICDs related to a specific subset of circuit components which may have a low resistance path that could result in rapid battery depletion. Medtronic said that, based on its records, 53 of the 78 devices are still active. The low resistance path in the circuit can result in depletion of the battery in 7 days or less, Medtronic said, warning health care providers that the issue may present itself in follow up visits. The company said the issue could manifest in 1 or more electrical resets, lack of pacing or defibrillation therapy output, no telemetry or a programmer screen display of “SERIOUS DEVICE MEMORY FAILURE.” Medtronic warned that audible alerts and CareAlerts may not reliably notify the patient or clinician due to the issue. A total of 7 confirmed failures have been reported since July 16, Medtronic said. The company said it expects an additional 6 failures, as predicted by modeling, in the remaining active population. Reported complications include shortness of breath, pocket heating, low heart rate and early device expl...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance Medtronic Source Type: news