BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 2900958 · Received January 3, 2013

    Report

    Report Number
    3006556115-2012-00607
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT'S ELECTRODE ARRAY WAS PARTIALLY INSERTED IN THE COCHLEA. REVISION SURGERY WAS PERFORMED TO REINSERT THE ELECTRODE ARRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2537 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention