BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1161391 · Received September 12, 2008

    Report

    Report Number
    3006556115-2008-00455
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 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 INTERMITTENCIES WITH HIS INTERNAL DEVICE FOLLOWED BY A LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE ATTEMPTED; HOWEVER, THIS DID NOT RESOLVE THE PROBLEM. SURGERY TO EXPLANT THE PATIENT'S DEVICE HAS BEEN DISCUSSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR