BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION IMPLANT

    MDR report key: 3894544 · Received April 25, 2014

    Report

    Report Number
    3006556115-2014-00191
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED LOSS OF LOCK BETWEEN THE EXTERNAL EQUIPMENT AND THE COCHLEAR IMPLANT. EXTERNAL EQUIPMENT WAS EXCHANGED; BUT, THE ISSUE WAS NOT RESOLVED. ADDITIONAL TESTING COULD NOT BE COMPLETED DUE TO LOSS OF LOCK. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252751 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR