The medtech giant warned healthcare professionals that there is the potential for reduced shock energy — around 79% of programmed energy — during high-voltage (HV) therapy for all Cobalt and Crome ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds).
According to the notice, through June 3, 2022, Medtronic identified 27 devices (comprising 0.03% of devices distributed worldwide) that have experienced a reduced-energy shock, which is accompanied by a short circuit protection (SCP) alert. No reports of permanent harm or death have been reported in relation to the issue, and Medtronic has submitted a device software update to address the issue. It expects the update to be available for download into implanted devices beginning in the third or fourth quarter of calendar year 2022, pending regulatory approvals.
Medtronic said that the potential for reduced-energy shock is the result of the SCP safety feature designed to truncate delivered energy to protect the device when an unexpected current is detected during HV therapy. All Cobalt and Crome devices include the SCP feature, and SCP events can trigger during the delivery of HV biphasic waveform in the presence of lead insulation breach (typically first-phase SCP) or unexpected, additional current in the device HV circuit (typically second-phase SCP).
The warning impacts four models of the Cobalt XT, four models of the Cobalt and four models of the Crome devices. Medtronic requested that hospitals quarantine and return a subset of non-implanted Cobalt and Crome ICDs and CRT-Ds so that the devices may undergo additional inspection to ensure conformance to manufacturing specifications.
Medtronic’s latest warning for ICDs follows a serious recall of the devices in the U.S. in April of last year, with the FDA classifying it as Class I. That recall, which involved 239,171 ICDs and CRT-Ds, was attributed to potential battery life problems. It was related to 444 complaints regarding Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia and Visia devices.