BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1140554 · Received August 28, 2008

    Report

    Report Number
    3006556115-2008-00428
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY HIT BY A BASEBALL BAT OVER HER CONTRALATERAL IMPLANT SITE. THE PATIENT BELIEVES HER INTERNAL DEVICE HAS MOVED. THE IMPLANT SURGEON HAS DISCUSSED THE POSSIBILITY OF REPOSITIONING THE DEVICE. TESTING OF THE DEVICE SHOWED THAT THE DEVICE IS FUNCTIONING. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION, ONCE MORE INFORMATION 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 314714 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR