BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3230136 · Received July 16, 2013

    Report

    Report Number
    1644487-2013-02149
    Event Type
    Death
    Date Received
    July 16, 2013
    Date of Event
    January 18, 2013
    Report Date
    June 20, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS A CERVICAL FRACTURE. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION; HOWEVER, THEY HAVE BEEN UNSUCCESSFUL. PER THE OBITUARY, THE PATIENT PASSED AWAY ON (B)(6) 2013. FOLLOW UP WITH THE FUNERAL HOME FOUND THAT THE PATIENT WAS BURIED WITH THE VNS DEVICE; THEREFORE THE DEVICE WILL NOT BE RETURNED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329746 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 200670

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| O