BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1963463 · Received December 20, 2010

    Report

    Report Number
    9710014-2010-00409
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 20, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    AUDIOLOGIST

    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 PATIENT'S PERFORMANCE IS DETERIORATING. LATEST TESTING SHOWS A SHORT CIRCUIT BETWEEN ELECTRODES 6 AND 12, AND ELECTRODES 7, 8, 10 AND 11 IN STATUS HI. PREVIOUS TESTINGS SHOWED: INTRAOPERATIVE IN (B)(6) 2008: ELECTRODE 5 AND 12 IN STATUS HI; IN (B)(6) 2010: A SHORT CIRCUIT BETWEEN ELECTRODES 6 AND 12; AND IN (B)(6) 2010: ADDITIONALLY ELECTRODE 11 IN 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 SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR