Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.The device was returned and screening analysis was performed, but no issue was identified requiring full analysis.If information is provided in the future, a supplemental report will be issued.
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It was reported that, since the implantable cardiac monitor (icm) implantation procedure, the patient experienced severe pain and sensitivity to the implant site due to an infection that was described as "warm, red (and) pus-filled." the patient was given antibiotics and the device was explanted.No further patient complications have been reported as a result of this event.
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