BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3940980 · Received June 24, 2014

    Report

    Report Number
    9710014-2014-00303
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER 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 IN SITU TESTING FROM (B)(6) 2014, SHOWED NORMAL RESULTS AND THE PT HAD NORMAL HEARING PERFORMANCE WITH THE DEVICE. THE PT HAD A CAR ACCIDENT 6 WEEKS AGO. ON (B)(6) 2014 THE PT HAD NO LONGER ANY ACCESS TO SOUND WITH THE DEVICE AND IN SITU TESTING FROM (B)(6) 2014, SHOWED THAT THE DEVICE HAD MALFUNCTIONED. THE PT WAS RE-IMPLANTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367540 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention