BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1842344 · Received August 30, 2010

    Report

    Report Number
    9710014-2010-00278
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 26, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 TWO WEEKS AGO THE PT HEARD A BANDING NOISE FROM HER COCHLEAR IMPLANT; IT THEN BECAME INTERMITTENT IN SOUND DURING THE DAY AND EVENTUALLY STOPPED WORKING. SINCE THIS EPISODE SHE HAS HEARD NO SOUND. THE AUDIOLOGIST INITIALLY SUSPECTED THE PROBLEM TO BE WITH THE PROCESSOR AND REPROGRAMMED A NEW ONE. HOWEVER, THIS WAS NOT THE CASE, AS THE PT COULD STILL NOT HEAR ANY SOUNDS AND BOTH PROCESSORS SEEMED TO BE FUNCTIONING NORMALLY. FOLLOWING THIS, THE PT'S AUDIOLOGIST CARRIED OUT TESTING WHICH SHOWED THAT THE DEVICE HAS MALFUNCTIONED.

    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 27 YR