BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1841239 · Received September 13, 2010

    Report

    Report Number
    3006556115-2010-00447
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT REPORTEDLY EXPERIENCED LOSS OF LOCK WITH THE INTERNAL DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED. HOWEVER, THE PROBLEM WAS NOT RESOLVED. SURGERY TO EXPLANT THE PATIENT'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 6 YR