BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1060162 · Received June 11, 2008

    Report

    Report Number
    3006556115-2008-00300
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 13, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS REPORTEDLY EXPERIENCING INTERMITTENCIES WITH HIS INTERNAL DEVICE. IT WAS REPORTED THAT THE PATIENT HIT HIS HEAD IN 2007, AND IT WAS CONFIRMED THAT THIS CAUSED MAGNET DISPLACEMENT. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE ATTEMPTED HOWEVER THIS DID NOT RESOLVE THE PROBLEM. TESTING OF THE DEVICE SHOWS THAT THE DEVICE IS FUNCTIONING. SURGERY TO REPOSITION THE MAGNET WILL BE SCHEDULED.

    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