BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1242203 · Received November 24, 2008

    Report

    Report Number
    9710014-2008-00364
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 3, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD 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 SINCE 2007 THE GROUND PATH IMPEDANCE HAS INCREASED FROM 1,13 KOHM TO 8,78 KOHM. DUE TO THE HIGHLY INCREASED GROUND PATH IMPEDANCE, IT WAS ASSUMED THAT THE REFERENCE ELECTRODE WAS DAMAGED, PROBABLY AS A RESULT OF AN EXTERNAL IMPACT TO THE IMPLANTED SIDE. ACCORDING TO THE PATIENT'S MOTHER, HER SON FALLS REGULARLY ON HIS HEAD. THE PATIENT WAS RE-IMPLANTED IN 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 3 YR Required Intervention