BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3934697 · Received July 15, 2014

    Report

    Report Number
    1644487-2014-01775
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 17, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S DEVICE WAS NOT EXPLANTED BUT REPOSITIONED DURING THE MASTECTOMY. THE DEVICE WAS PROGRAMMED ON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WILL UNDERGO A LEFT MASTECTOMY DUE TO BREAST CANCER. THE RELATIONSHIP OF THE CANCER TO VNS IS UNKNOWN. CLINIC NOTES INDICATE THAT DURING THE MASTECTOMY, THE GENERATOR WOULD BE MOVED AWAY FROM THE BREAST. THE PATIENT UNDERWENT LEFT MASTECTOMY AS PLANNED. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413593 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200618

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention