BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2181166 · Received July 8, 2011

    Report

    Report Number
    9710014-2011-00210
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Report Date
    July 4, 2011
    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 MFR FOR EVAL. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TESTING CARRIED OUT IN JUNE SHOWED STATUS HI FOR CHANNELS 1-11 AND STATUS SC FOR CHANNEL 8 AND 11. THE PT GOT DEAF DUE TO MENINGITIS. RECENTLY SHE DEVELOPED A STREPTOCOCCUS INFECTION, WHICH WAS TREATED WITH ANTIBIOTICS. THEREAFTER, THE MOTHER RECOGNIZED THAT THE PT NO LONGER REACTS ON SPEECH ON THIS EAR. OSSIFICATION IS SUSPECTED. HIGH IMPEDANCES WERE TRIED TO BE REDUCED BY CORTISONE THERAPY LAST YEAR IN WINTER, BUT THE SITUATION DID NOT IMPROVE. AN IMPACT TO THE IMPLANT IS NOT KNOWN.

    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 PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR