BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1971501 · Received January 21, 2011

    Report

    Report Number
    9710014-2011-00020
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    January 16, 2011
    Report Date
    January 19, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MFR FOR EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT CAN NO LONGER HEAR WITH HIS DEVICE. A HISTORY OF HEAD TRAUMA HAS NOT BEEN REPORTED. AN X-RAY HAS BEEN CARRIED OUT SHOWING NO TRAUMA TO THE IMPLANT AND THAT THE REFERENCE ELECTRODE AND MAIN ELECTRODE ARE PLACED CORRECTLY. TESTING SHOWS CHANNELS 1, 2, 3, 4, 5, 7, 9 AND 12 IN STATUS HI. CHANNELS 6, 10, AND 11 COULD NOT BE MEASURED. CHANNEL 8 IS IN STATUS OK. THE PT WAS RE-IMPLANTED ON (B)(6) 2011.

    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 7 YR Required Intervention