BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 707540 · Received May 2, 2006

    Report

    Report Number
    9710014-2006-00112
    Event Type
    Malfunction
    Date Received
    May 2, 2006
    Date of Event
    April 25, 2005
    Report Date
    April 28, 2006
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL ON APRIL 25, 2006 WHILST AT SCHOOL OR ON THE BUT ( IT IS NOT CLEAR). ON APRIL 26, THAT PATIENT REPORTED THAT WHEN HE PUT ON HIS SPEECH PROCESSOR, HE WAS NO LONGER ABLE TO HEAR. TESTING SHOWED THA TCHANNELS 1-9 AND 11 HAD HIGH IMPEDANCE

    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 PULSAR *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR