BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 387561 · Received April 1, 2002

    Report

    Report Number
    2029203-2002-00064
    Event Type
    Malfunction
    Date Received
    April 1, 2002
    Report Date
    April 1, 2002
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT HAS REPORTED ON-GOING PROBLEMS OF INTERMITTENT LOSS OF LOCK. EXTERNAL HARDWARE HAS BEEN EXCHANGED WITHOUT RESOLUTION TO THE REPORTED PROBLEM. IN 03/2002, A CO REP VISITED THE CENTER TO PERFORM TESTING ON THE DEVICE. TESTING CONDUCTED CONFIRMED THAT DEVICE WAS NOT FUNCTIONING. REVISION SURGERY HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS CORP. AB-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR