BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3211041 · Received July 8, 2013

    Report

    Report Number
    1644487-2013-02043
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH CANCER. THE LOCATION OF THE CANCER IS UNKNOWN. ATTEMPTS TO CONTACT THE PHYSICIAN FOR ADDITIONAL INFORMATION WERE MADE AND WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311404 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS 103 3391

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other