BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1031938 · Received April 22, 2008

    Report

    Report Number
    9710014-2008-00110
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Report Date
    April 14, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 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 SUDDENLY A FEW DAYS AGO, THE PT WAS NO LONGER ABLE TO HEAR WITH HIS SPEECH PROCESSOR. AFTER HE TOOK OFF THE SPEECH PROCESSOR AND PUT IT ON AGAIN, IT WORKED AGAIN FOR HALF A DAY, BUT SINCE THEN IT HAS STOPPED WORKING. ALL THE EXTERNAL PARTS WERE EXCHANGED BUT WITHOUT SUCCESS. TESTING CONFIRMED THAT THE DEVICE HAS MALFUNCTIONED. RE-IMPLANTATION SURGERY IS SCHEDULED FOR END OF APRIL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR