BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1021410 · Received March 24, 2008

    Report

    Report Number
    3006556115-2008-00146
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTS EXPERIENCING A LOSS OF SOUND WITH THE DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED AND REPROGRAMMING WAS ATTEMPTED; HOWEVER, THE PROBLEM HAS NOT BEEN RESOLVED. THE PT'S DEVICE WAS EXPLANTED AND RE-IMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01

    Patients

    Seq Age Sex Outcome Treatment
    1