BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2231621 · Received August 18, 2011

    Report

    Report Number
    3006556115-2011-00397
    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
    WA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCES SHOCKS, DIZZINESS, AND DISCOMFORT LEADING TO HEADACHES WHEN USING THE DEVICE. TESTING REVEALED THAT THE DEVICE IS FUNCTIONING. THE SURGEON WILL PURSUE DEVICE REVISION SURGERY.

    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 24 YR