BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1082468 · Received July 25, 2008

    Report

    Report Number
    3006556115-2008-00358
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE IMPLANT SURGEON WAS ATTEMPTING TO DRILL THE COCHLEOSTOMY, HE ENCOUNTERED TISSUE WITHIN THE COCHLEA. FURTHER, UPON TRYING TO DRILL ANOTHER COCHLEOSTOMY AROUND THAT POINT, THE IMPLANT SURGEON ENCOUNTERED BLEEDING, WHICH COULD NOT BE CONTROLLED. THE IMPLANT SURGEON ATTEMPTED TO DRILL IN TWO OTHER LOCATIONS BUT COULD NOT FIND THE COCHLEA. 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 NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention