BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1915390 · Received November 3, 2010

    Report

    Report Number
    9710014-2010-00347
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT FIRST FITTING, THE IMPEDANCE AND VOLTAGES ON THE APICAL ELECTRODES WERE HIGH. A MAJOR INCREASE OF IMPEDANCE AND VOLTAGES WAS SEEN DURING 3RD FITTING, AND CHANNEL 11 SHOWED IN THE STATUS HI. IN THE TIME PERIOD BETWEEN (B)(6) 2008 AND (B)(6) 2010, THE IMPEDANCE AND VOLTAGES INCREASED SO MUCH THAT THE PT DID NOT HAVE THE EXPECTED BENEFIT FROM HER COCHLEAR IMPLANT. TESTING CARRIED OUT ON (B)(6) 2010 SHOWS 5 CHANNELS IN THE STATUS HI.

    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 4 YR