Premature battery depletion of EMBLEM subcutaneous implantable cardioverter‐defibrillators.

The EMBLEM subcutaneous implantable cardioverter defibrillator (S‐ICD) has an expected longevity of 7 years. In August 2019, Boston Scientific released an advisory regarding a limited subset of ~400 S‐ICDs that exhibited an increased likelihood of an electrical component malfunction causing accelerated battery depletion. We observed several cases of nonadvisory S‐ICD early battery depletion and sought to systematically evaluate the cohort of EMBLEM devices implanted and followed in our medical center. Out of 118 nonadvisory EMBLEM S‐ICDs with a median time to most recent follow‐up after implant of 735 days (interquartile range 375–1219 days), there were four premature battery failures identified. Serial device interrogations showed a sudden reduction in battery life at 1 195, 1 205, 1 300, and 678 days after implant. The number of shocks delivered during the lifetime of the devices did not explain the premature depletion. There was a sudden departure from the gradual linear decrease in battery longevity observed over time. We are the first to report a signal of premature battery depletion among S‐ICD EMBLEM devices that were not among the initial advisory devices. The prevalence of premature battery failure in our cohort was 3.4%, occurring at an average of 1 095 days. Following these reports, Boston Scientific issued an advisory on EMBLEM devices in December 2020 extending beyond the initial advisory subset. The current projected occurrence rate for hydrogen‐induced accelerated battery depletion is 3.7% at 5 years. Increased surveillance of this potential device issue and mitigation to identify patients at risk for this is warranted. [ABSTRACT FROM AUTHOR]

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