BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2142096 · Received May 25, 2011

    Report

    Report Number
    9710014-2011-00165
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Report Date
    May 19, 2011
    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 THE IMPLANTATION SURGEON FOR THIS PT WAS VERY DIFFICULT DUE TO OSSIFICATION. AT INITIAL ACTIVATION ONLY 3 ELECTRODES COULD BE ACTIVATED. AT THE 5TH FITTING ON (B)(6), 2010, NO GPI COULD BE MEASURED. DURING THE LAST FITTING ON (B)(6), 2011, TESTING SHOWED 10 ELECTRODE CHANNELS IN STATUS HI AND 2 ELECTRODE CHANNELS IN STATUS SC.

    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 7 YR