BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2063810 · Received April 4, 2011

    Report

    Report Number
    3006556115-2011-00147
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT IS REPORTEDLY EXPERIENCING POOR PERFORMANCE WITH HIS INTERNAL DEVICE. TESTING OF THE DEVICE SHOWED ABNORMAL RESULTS. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO.

    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 22 YR