BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2221219 · Received August 24, 2011

    Report

    Report Number
    1644487-2011-01967
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(6), 2011 A NURSE REPORTED THAT THE VNS PATIENT WAS DIAGNOSED WITH RIGHT BREAST CANCER AND THE RADIATION WOULD BE PERFORMED ON THAT SIDE ONLY OF THE PATIENT. THE NURSE DID NOT HAVE ANY INFORMATION ON THE CAUSE OR RELATIONSHIP OF THE CANCER TO THE VNS. THE PATIENT'S PHYSICIAN WAS CONTACTED BUT HIS ASSISTANT REPORTED THAT THEY WOULD NOT KNOW ANYTHING ABOUT THE PATIENT'S CANCER AND TO CALL THE ONCOLOGIST. GOOD FAITH ATTEMPTS WERE MADE FOR FURTHER INFORMATION FROM THE PATIENT'S ONCOLOGIST BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 2349

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention