BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1172930 · Received September 19, 2008

    Report

    Report Number
    3006556115-2008-00486
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 1, 2008
    Report Date
    August 21, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED SOUND QUALITY ISSUES, FOLLOWED BY OVERLY LOUD SENSATION. TESTING CONFIRMED THAT DEVICE IS NOT FUNCTIONING. THE PATIENT'S DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR