BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2093867 · Received April 6, 2011

    Report

    Report Number
    9710014-2011-00116
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 30, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    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 IS BILATERALLY IMPLANTED. SHE NOTED THAT THE SOUND OF THE IMPLANT ON THE CONTRALATERAL EAR HAD CHANGED, IT BECAME WEAKER AND DISTORTED. SHE VISITED THE CLINIC, WHERE IT WAS CONFIRMED THAT BOTH DEVICES HAD MALFUNCTIONED. CONCERNING THIS IMPLANT, THE PATIENT'S COCHLEA WAS OSSIFIED. THIS DEVICE WITH A SPLIT ELECTRODE WAS IMPLANTED, HOWEVER, THE PATIENT DID NOT RECEIVE SUFFICIENT BENEFIT WITH THIS DEVICE.

    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 28 YR