BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI +40 COCHLEAR IMPLANT SYSTEM

    MDR report key: 2833450 · Received October 30, 2012

    Report

    Report Number
    9710014-2012-00387
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 25, 2012
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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, IMPLANTED IN 2001, STOPPED HAVING ACCESS TO SOUND FROM ONE MOMENT TO THE NEXT. HE FELT A FACIAL AND AUDITORY SENSATION IN THE MOMENT HE STOPPED HEARING. THEN HE PERCEIVED SOUND FOR A COUPLE OF MINUTES AND STOPPED AGAIN, AND DIDN'T RETURN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR