BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1961437 · Received January 5, 2011

    Report

    Report Number
    3006556115-2010-00681
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    December 18, 2010
    Report Date
    December 18, 2010
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED LOSS OF SOUND. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING CHANGES HAVE BEEN MADE. HOWEVER, THE PROBLEM HAS NOT RESOLVED. THE TESTING OF THE DEVICE SHOWED THAT ALL ELECTRODES WERE OPEN. REVISION SURGERY IS BEING CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR