BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1032882 · Received April 23, 2008

    Report

    Report Number
    3006556115-2008-00189
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT IS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES WITH HER INTERNAL DEVICE. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THIS DID NOT RESOLVE THE PROBLEM. TESTING OF THE DEVICE SHOWED THAT THE DEVICE IS FUNCTIONING. SURGERY TO EXPLANT THE PT'S DEVICE WILL BE SCHEDULED.

    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