BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2093881 · Received April 6, 2011

    Report

    Report Number
    9710014-2011-00112
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 PATIENT FELL ONTO HER HEAD AFTER IMPLANTATION SURGERY. SHE HAS SEVERE NEUROLOGICAL PROBLEMS FOLLOWING A HEAD TRAUMA SEVERAL YEARS AGO. SHE IS ALWAYS IN HYPER PRESSURE DURING BREATHING, AND DURING THE NIGHT SHE NEEDS ASSISTANCE TO BREATHE. AT ACTIVATION, THE GROUND PATH IMPEDANCE WAS VERY HIGH AND NO STIMULATION WAS POSSIBLE. THE SURGEON DECIDED TO APPLY A COMPRESSIVE BAND FOR A MONTH. AFTER THIS PERIOD, THE SITUATION WORSENED. TWO MONTHS AGO, A BIG AIR BUBBLE APPEARED AND THE PATIENT UNDERWENT A REVISION SURGERY. TODAY THE SITUATION IS THE SAME. THERE IS NO IMPROVEMENT AND NO CI STIMULATION IS POSSIBLE. TESTING CARRIED OUT ON (B)(6) 2011 SHOWS 10 ELECTRODE CHANNELS IN STATUS HI AND NO GROUND PATH IMPEDANCE (GPI) COULD GET MEASURED.

    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 SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR