BEUDAMED
    FDA Adverse Event Other Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 801517 · Received January 3, 2007

    Report

    Report Number
    9710014-2007-00004
    Event Type
    Other
    Date Received
    January 3, 2007
    Date of Event
    December 31, 2006
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. ADDITIONALLY, INFORMATION FROM FURTHER CLINICAL ASSESSMENT WAS REQUESTED. WHEN AVAILABLE, AN ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS DIAGNOSED IN 2006 WITH BACTERIAL MENINGITIS. THE PT HAS SEVERAL OTHER DIAGNOSIS IN ADDITION TO THE MENINGITIS. THE PATIENT'S MOTHER REPORTED THAT THE BACTERIAL MENINGITIS WAS THE MAIN DIAGNOSIS. THE MOTHER REPORTED THAT THE PATIENT WAS ON ANTIBIOTICS AND UNDER CLOSE OBSERVATION. THE PT WAS PLACED ON A VENTILATOR TO ASSIST WITH HER BREATHING.

    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 17 YR Life Threatening