BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3853370 · Received April 7, 2014

    Report

    Report Number
    9710014-2014-00161
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 25, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ONE WEEK EARLIER HAD BEEN HIT ON HER LEFT IMPLANT WITH A TENNIS BALL WHILST DOING SPORT AT SCHOOL. THE PATIENT REPORTED TWINGES AND PAIN. PATIENT HAS BEEN EXPERIENCING INTERMITTENT TWITCHING FOR THE LAST 6 BUT NOT AS SEVERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208990 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSAR H STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR