BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1211363 · Received October 22, 2008

    Report

    Report Number
    3006556115-2008-00570
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED SOUND QUALITY ISSUES. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE. HOWEVER, THIS DID NOT RESOLVE THE ISSUE. TESTING OF THE DEVICE CONFIRMED THAT IT IS FUNCTIONING. SURGERY TO EXPLANT THE PATIENT'S DEVICE IS UNDER CONSIDERATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR