BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3001412 · Received March 8, 2013

    Report

    Report Number
    9710014-2013-00085
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 PT WAS EXPLANTED ON (B)(6) 2013, DUE TO AN EXTRUSION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98570 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM MED-EL CONCERT +STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention