BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION IMPLANT

    MDR report key: 2913490 · Received January 9, 2013

    Report

    Report Number
    3006556115-2012-00614
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCES SOUND QUALITY ISSUES AND PAIN WHILE WEARING THE EXTERNAL EQUIPMENT. EXTERNAL EQUIPMENT WAS EXCHANGED. DEVICE TESTING INDICATES THAT THE DEVICE IS NOT FUNCTIONING WITHIN SPECIFICATIONS. DEVICE REVISION SURGERY HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13024 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR