BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1061519 · Received June 17, 2008

    Report

    Report Number
    3006556115-2008-00314
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 29, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED A LOSS OF LOCK WITH HER INTERNAL DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE ATTEMPTED HOWEVER THIS DID NOT RESOLVE THE PROBLEM. THE PT'S INTERNAL DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR