BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1241170 · Received November 20, 2008

    Report

    Report Number
    1644487-2008-02773
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    January 1, 2007
    Report Date
    October 22, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A PATIENT HAD HER DEVICE REPLACED BECAUSE HER PREVIOUS DEVICE WAS CAUSING SOME CHEST PAIN. FOLLOW UP WITH THE PATIENT'S TREATING PHYSICIAN REVEALED THAT THE PAIN THE PATIENT REPORTED IS A CONTINUATION OF PAIN REPORTED LAST YEAR THAT OCCURRED AFTER THE PATIENT WENT THROUGH A METAL DETECTOR AT THE AIRPORT; HOWEVER, NOW INTERVENTION ARE BEING TAKEN. THE PATIENT HAD HER DEVICE REPLACED AND HAS BEEN DOING VERY WELL SINCE THE SURGERY. THE EXPLANTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS AND NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS WERE FOUND WITH THE GENERATOR. THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102 014911

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention