BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1267891 · Received November 18, 2008

    Report

    Report Number
    9710014-2008-00363
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Report Date
    October 31, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 DURING A ROUTINE TESTING IT WAS FOUND THAT ONLY 4 CHANNELS ARE OK. TWO SHORT-CIRCUITS HAVE BEEN DETECTED. KS-A INVOLVES ELECTRODE CHANNELS 2, 5, 6, 7 AND KS-B INVOLVES ELECTRODE CHANNELS 9, 11 AND 12. ELECTRODE CHANNEL 10 SHOWS STATUS 'HI'. 8 ELECTRODE CHANNELS WERE DEACTIVATED.

    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 8 YR