BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3813391 · Received March 31, 2014

    Report

    Report Number
    9710014-2014-00170
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 27, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 IN SITU TESTING SHOWED THAT THE DEVICE, IMPLANTED IN 1998, HAS MALFUNCTIONED. HOWEVER, THE PATIENT STILL HAS ACCESS TO SOUND. THE PATIENT IS SUPPOSED TO VISIT THE CLINIC IF ANY CHANGE IN HEARING PERFORMANCE IS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190004 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR