Patient was implanted with a guardian device on (b)(6) 2022.Patient was alerted by the guardian system via a see doctor alert on (b)(6) 2023 and made an appointment to see the cardiologist for (b)(6) 2023.At that appointment the device was interrogated and it was identified that a device reset had occurred.Further evaluation indicated that the device could no longer reliably communicate with the programmer.The physician was notified and discussed the problem with the patient and indicated that the device should be explanted so that the root cause of the problem could be identified.The patient agreed to the explant and the device was explanted on (b)(6) 2023.The device was sent to decontamination facility and was received at avertix medical inc.On (b)(6) 2023, the patient experienced no adverse events associated with this problem or the explant procedure.An investigation was initiated to determine the root cause of the problem.The following issue was created in the qms of avertix for this problem: issue 73 issue 73 was escalated to a complaint for investigation: complaint 51 complaint 51 was assigned to capa for corrective and preventive action determinations: capa 12.
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