BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI-40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 726029 · Received June 9, 2006

    Report

    Report Number
    9710014-2006-00158
    Event Type
    Malfunction
    Date Received
    June 9, 2006
    Date of Event
    May 25, 2006
    Report Date
    June 9, 2006
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED .

    Description of Event or Problem · 1

    THE PATIENT FELL AND HIT HIS HEAD ON MAY 25, 2006. THE TISSUE SURROUNDING THE IMPLANT WAS VERY SWOLLEN, EVEN THOUGH THERE WAS NO OUTER INJURY TO BE SEEN. THE PATIENT HAS BEEN UNABLE TO HEAR SINCE. TESTING CONFIRMED THAT THE DEVICE HAS MALFUNCTIONED.

    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 3 YR