BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 6364092 · Received February 28, 2017

    Report

    Report Number
    9710014-2017-00187
    Event Type
    Injury
    Date Received
    February 28, 2017
    Date of Event
    February 22, 2017
    Report Date
    June 14, 2017
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE INVESTIGATION RESULTS CONFIRMED THAT THE DEVICE HAS FAILED DUE TO AN EXTERNAL IMPACT TO THE ACTIVE ELECTRODE. ALL THE PROBLEMS GIVEN IN THE PATIENT REPORT APPEAR TO MATCH WELL WITH THIS FINDING. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2017 THE PATIENT FELL AT THE PLAYGROUND AND BANGED HIS HEAD ON IMPLANT SIDE ON A PIECE OF METAL. HE CAN NO LONGER HEAR WITH THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2017 THE PATIENT FELL IN THE PLAYGROUND AND BANGED HIS HEAD ON THE IMPLANT SIDE ON A PIECE OF METAL. HE CAN NO LONGER HEAR WITH THE DEVICE. THERE IS NO BREAK TO THE SKIN, REDNESS OR SWELLING. THE PROCESSOR IS STILL WORKING NORMALLY. THE PATIENT WAS RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149198 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1200 SYNCHRONY

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention