BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3853181 · Received April 2, 2014

    Report

    Report Number
    3006556115-2014-00143
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED LOSS OF SOUND FOLLOWED BY LOSS OF LOCK WITH INTERNAL DEVICE. PROGRAMMING CHANGES WERE MADE AND EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THE ISSUE WAS NOT RESOLVED. DEVICE REVISION SURGERY IS BEING CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199957 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR