BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1820111 · Received August 23, 2010

    Report

    Report Number
    9710014-2010-00267
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 19, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CARRIED OUT ON (B)(4), 2010, 10 OR 12 OF THE 12 ELECTRODE CHANNELS SHOWED HI IMPEDANCE VALUES. THE PT IS NO LONGER WEARING HIS DEVICE AS HE GAINS NO BENEFIT FROM IT.

    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 24 YR