BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1063126 · Received June 23, 2008

    Report

    Report Number
    9710014-2008-00200
    Event Type
    Injury
    Date Received
    June 23, 2008
    Date of Event
    April 1, 2008
    Report Date
    June 16, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO THE MFR, WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PARENTS COMPLAINED TO THE DISTRIBUTOR THAT THE PATIENT WAS ONLY ABLE TO HEAR VERY WEAK SOUNDS IN 2008, AND THEN WAS NO LONGER ABLE TO HEAR ANY SOUNDS IN THE FOLLOWING MONTH. HIS PARENTS STATED THAT NO ACCIDENT OR HEAD IMPACT HAD OCCURRED BEFORE HE COMPLAINED ABOUT HEARING ONLY VERY WEAK SOUNDS. HOSPITAL STAFF CONDUCTED TESTING AND IT WAS SEEN THAT THE DEVICE HAD MALFUNCTIONED. HOSPITAL STAFF CHECKED PATIENT'S TEMPO+ SYSTEM AND FOUND THE SYSTEM WAS WORKING PROPERLY. BASED UPON THE REPORTS FROM THE HOSPITAL STAFF, A REVISION SURGERY WAS RECOMMENDED AS SOON AS POSSIBLE.

    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 13 YR Required Intervention