BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1122356 · Received August 18, 2008

    Report

    Report Number
    9710014-2008-00260
    Event Type
    Malfunction
    Date Received
    August 18, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 6, 2008
    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 EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE TWO WEEKS THE PATIENT HAS NO LONGER WORN HER SPEECH PROCESSOR ON HER RIGHT HAND SIDE DUE TO FLUCTUATING IMPEDANCES. ON (B) (6) 2007 TESTING WAS CARRIED OUT WHICH SHOWED FLUCTUATING IMPEDANCES ON SEVERAL CHANNELS. THESE CHANNELS WERE DEACTIVATED AND REGULAR APPOINTMENTS WERE SCHEDULED. ON (B) (6) 2008, TESTING WAS CARRIED OUT AGAIN, WHICH SHOWED HIGH ON 4-6 CHANNELS AND INCREASED IMPEDANCES ON 1-2 CHANNELS. DUE TO THE FLUCTUATING IMPEDANCES, RE-IMPLANTATION IS SCHEDULED FOR (B) (6) 2008.

    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 10 YR