BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GE MODEL 102

    MDR report key: 4091894 · Received August 20, 2014

    Report

    Report Number
    1644487-2014-02052
    Event Type
    Death
    Date Received
    August 20, 2014
    Date of Event
    June 25, 2007
    Report Date
    July 22, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MORTUARY REPORTED THAT THERE ARE NO RECORDS FOR THE PATIENT, SO IT WAS UNABLE TO BE DETERMINED WHETHER OR NOT THE PATIENT WAS BURIED OR CREMATED; HOWEVER, STANDARD PROCEDURE IS THAT PATIENTS BE BURIED WITH DEVICES OR EXPLANT AND DISCARD THE DEVICE IF THE PATIENT IS CREMATED. THE DEATH CERTIFICATE IS UNABLE TO BE OBTAINED BY THE STATE OF DEATH. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. THE PATIENT'S ONLINE OBITUARY INDICATED THE PATIENT'S DATE OF DEATH AND THAT THE PATIENT PASSED AWAY AT THE HOSPITAL. THE CAUSE OF DEATH IS UNKNOWN. THE RELATIONSHIP TO VNS IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE CAUSE OF DEATH WAS LISTED AS SEPTICEMIA, ENCEPHALOPATY, RESPIRATORY FAILURE, CARDIAC ARREST AND USPECIFIED RENAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503735 PULSE GE MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 010388

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death