BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3190728 · Received June 24, 2013

    Report

    Report Number
    3006556115-2013-00269
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT IS REPORTEDLY EXPERIENCING HEADACHES AND SOUND QUALITY ISSUES. PROGRAMMING ADJUSTMENTS HAVE BEEN MADE AND EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER, THIS DID NOT RESOLVE THE ISSUE. REVISION SURGERY IS UNDER CONSIDERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286391 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR