It was reported a patient presented for an implant procedure on (b)(6) 2023.During procedure it was noted the implantable cardioverter defibrillator (icd) right ventricular port did not work.There was also noise, under-sensing, and loss of capture noted.The device was not used and replaced within the same operation.Post-procedure the patient was stable.
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The reported field events of connection anomaly, capture and sensing issues could not be reproduced in the lab.Upon receipt, the device was above elective replacement indicator (eri).Visual inspection of the septum, setscrew and contact spring did not reveal any anomaly.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.
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