BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2973782 · Received April 13, 2007

    Report

    Report Number
    9710014-2007-00098
    Event Type
    Malfunction
    Date Received
    April 13, 2007
    Date of Event
    April 1, 2007
    Report Date
    April 13, 2007
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FIT AND HIT HER HEAD WITH HER FISTS. TESTING CONFIRMED THAT THE DEVICE HAS MALFUNCTIONED AS 9 CHANNELS SHOW HIGH IMPEDANCES.

    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 C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR