BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 3810705 · Received March 21, 2014

    Report

    Report Number
    3006556115-2014-00113
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 25, 2014
    Report Date
    February 25, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED LOSS OF SOUND AND LOSS OF LOCK WITH INTERNAL DEVICE. PROGRAMMING CHANGES WERE MADE, AND EXTERNAL EQUIPMENT HAS BEEN EXCHANGED. THE ISSUE WAS NOT RESOLVED. DEVICE REVISION SURGERY WILL BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169205 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR