BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 413016 · Received August 19, 2002

    Report

    Report Number
    1066702-2002-00083
    Event Type
    Malfunction
    Date Received
    August 19, 2002
    Date of Event
    July 16, 2002
    Report Date
    July 18, 2002
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S PARENTS AND TEACHERS HAD SEEN A DECREASE IN THE PT'S PERFORMANCE. TELEMETRY PERFORMANCE WAS CHECKED IN BOTH EXPERT AND NORMAL MODES IN 07/2002 AND AGAIN IN 08 /2002.

    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 10 YR