BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1203344 · Received October 15, 2008

    Report

    Report Number
    3006556115-2008-00532
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED LOSS OF SOUND AND TESTS REVEALED ZERO IMPEDANCES ON ALL ELECTRODES. THE COMPANY IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION AND WILL SUBMIT SUPPLEMENTAL REPORT ONCE NEW INFORMATION IS OBTAINED.

    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 7 YR