BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3874971 · Received June 2, 2014

    Report

    Report Number
    9710014-2014-00267
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    February 21, 2014
    Report Date
    May 17, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO INNSBRUCK WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A DECREASE IN PERFORMANCE WAS NOTED SINCE (B)(6) 2013. HEAD TRAUMA IS DENIED. THE PATIENT WAS EXPLANTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321860 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSAR STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention