BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2090832 · Received May 10, 2011

    Report

    Report Number
    3006556115-2011-00233
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT REPORTEDLY EXPERIENCED SOUND QUALITY ISSUES WITH HIS DEVICE. TESTING THE DEVICE REVEALED OUT OF RANGE IMPEDANCES. SURGERY TO EXPLANT THE PATIENT'S DEVICE WILL BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention