BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 716594 · Received May 19, 2006

    Report

    Report Number
    9710014-2006-00137
    Event Type
    Malfunction
    Date Received
    May 19, 2006
    Date of Event
    March 1, 2006
    Report Date
    May 17, 2006
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT DOES NOT RESPOND TO AUDITORY STIMULATION. NWE PROGRAMMING WAS CARRIED OUT IN AN ATTEMPT TO RAISE PULSE DURATIONS TO SE IF THRE WAS ANY RESPONSE. HOWEVER, THERE WAS NO RESPONSE AND RE-IMPLANTATION IS NOW UNDER DISCUSSION.

    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 3 YR