BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 2231628 · Received August 18, 2011

    Report

    Report Number
    3006556115-2011-00398
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENCIES AND EVENTUAL LOSS OF SOUND WHILE USING HER COCHLEAR IMPLANT. THE PATIENT HAS HAD SEVERAL EQUIPMENT CHANGES; BUT, THE ISSUE HAS NOT RESOLVED. THE PATIENT HAS BEEN REFERRED TO THE SURGEON FOR DEVICE REVISION SURGERY.

    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 79 YR