BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1133422 · Received August 22, 2008

    Report

    Report Number
    3006556115-2008-00439
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY WAS HIT WITH A BALL AT THE IMPLANT SITE. THE PT REPORTEDLY EXPERIENCES NO HEARING SENSATION. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE. HOWEVER, THIS DID NOT RESOLVE THE ISSUE. TESTS CONFIRMED THE DEVICE IS NOT FUNCTIONING. THE PT'S DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

    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