BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3011150 · Received March 15, 2013

    Report

    Report Number
    9710014-2013-00094
    Event Type
    Injury
    Date Received
    March 15, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD RECEIVED AN IMPACT ON HIS HEAD IN THE 1990S. THE PATIENT DID KICK-BOXING AT THAT TIME. SINCE THEN HE NO LONGER HAD ACCESS TO SOUND AND HAD BEEN A NON-USER. RECENTLY THE PATIENT HAD ANOTHER INJURY. THE PATIENT WAS EXPLANTED FROM HIS CI. THE DATE OF EXPLANTATION HAS NOT BEEN COMMUNICATED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110860 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention