BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3013069 · Received March 15, 2013

    Report

    Report Number
    9710014-2013-00096
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT FELL DOWN DUE TO DIZZINESS, AND AFTER THIS ACCIDENT, THE PT WAS NO LONGER ABLE TO HEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110409 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSAR STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR