BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2063818 · Received April 6, 2011

    Report

    Report Number
    3006556115-2011-00157
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY EXPERIENCING A DECREASE IN PERFORMANCE. SURGERY TO EXPLANT THE DEVICE IS UNDER CONSIDERATION AND ADDITIONAL DEVICE TESTING HAS BEEN 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 8 YR