BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2202289 · Received August 2, 2011

    Report

    Report Number
    3006556115-2011-00405
    Event Type
    Injury
    Date Received
    August 2, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCES PERIODIC LOSS OF SOUND AND FACIAL NERVE STIMULATION. TESTING OF THE DEVICE REVEALED THAT THE DEVICE IS FUNCTIONING NORMALLY. POST-OP IMAGING REVEALED THAT THE ELECTRODES ARE CORRECTLY PLACED. THE CENTER 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 Required Intervention