BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 2840807 · Received November 20, 2012

    Report

    Report Number
    1644487-2012-03078
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO REMOVE THE BREAST CANCER ON (B)(6) 2012. IT IS PROPOSED THAT THE PATIENT GET RADIATION THERAPY AFTER THE SURGERY AS WELL AS FURTHER TREATMENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A VNS REPORTED THAT SHE HAD BEEN RECENTLY DIAGNOSED WITH BREAST CANCER IN THE LEFT BREAST. SHE STATED THAT THE CANCER WAS NOT NEAR THE GENERATOR; HOWEVER, SHE WANTED INFORMATION ON PRECAUTIONS ASSOCIATED WITH VNS AND RADIATION THERAPY. THE PATIENT WAS DIRECTED TO HER PHYSICIAN TO OBTAIN THIS INFORMATION AND GOOD FAITH ATTEMPTS WERE MADE TO THE PHYSICIAN FOR ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE PHYSICIAN ON THIS PATIENT YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS, INC. 104 3033

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other