BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1122355 · Received August 18, 2008

    Report

    Report Number
    9710014-2008-00259
    Event Type
    Malfunction
    Date Received
    August 18, 2008
    Date of Event
    July 20, 2008
    Report Date
    August 5, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 FELL OUT OF HER BED TWICE AT WHICH SHE GOT INJURED ON HER HEAD. AFTER THE FIRST FALL SHE WAS STILL ABLE TO HEAR WITH HER DEVICE. HOWEVER, AFTER THE SECOND FALL WHICH OCCURRED ABOUT 5-6 MINUTES LATER, SHE WAS NO LONGER ABLE TO HEAR WITH HER DEVICE. A CT SCAN WAS CARRIED OUT WHICH SHOWED NORMAL RESULTS; HOWEVER, TESTING CONFIRMED THAT THE DEVICE HAS MALFUNCTIONED. A SECOND INVESTIGATION WILL BE CARRIED OUT AFTER THE SUTURE CLIPS HAVE BEEN REMOVED AND THE SWELLING HAS DISAPPEARED.

    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 32 MO