BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1081337 · Received July 24, 2008

    Report

    Report Number
    3006556115-2008-00384
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    July 21, 2008
    Report Date
    June 30, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED DIFFICULTIES WITH HEAD PIECE RETENTION DUE TO A THICK SKIN FLAP. THE HEAD PIECE RETENTION DIFFICULTIES RESULTED IN DRAINAGE FROM HIS INCISION SITE. THE IMPLANT SURGEON PRESCRIBED ORAL ANTIBIOTICS (TYPE UNKNOWN) AND INTRAVENOUS ANTIBIOTICS. THE PT'S DEVICE WAS EXPLANTED DUE TO SKIN FLAP INFECTION. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO, ONCE MORE INFO BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 Required Intervention