BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1934249 · Received November 23, 2010

    Report

    Report Number
    9710014-2010-00378
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUARDIANS NOTICED AN OBVIOUS DECLINE IN THE CHILD'S AUDITORY PERFORMANCE ONE WEEK AGO. HISTORY OF HEAD TRAUMA WAS DENIED BY THE GUARDIANS AND PROBLEMS OF OUTER DEVICE WERE EXCLUDED. TESTING CARRIED OUT ON (B)(6) 2010 SHOWED THAT THE DEVICE HAS MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR