BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2023810 · Received March 7, 2011

    Report

    Report Number
    3006556115-2011-00086
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    March 1, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY FELL AND HIT HIS HEAD AT THE IMPLANT SITE. X-RAY CONFIRMED THAT THE PATIENT'S INTERNAL MAGNET HAD MIGRATED. THE PT UNDERWENT SURGERY ON (B)(6), 2011 TO REPOSITION THE INTERNAL MAGNET. THE PT IS REPORTEDLY DOING WELL.

    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 3 YR Required Intervention