BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2220399 · Received August 23, 2011

    Report

    Report Number
    1644487-2011-01960
    Event Type
    Death
    Date Received
    August 23, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 30, 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
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS DISCOVERED THAT THE MANUFACTURER IS NOT ABLE TO OBTAIN THE PATIENT'S DEATH CERTIFICATE. ONLY THE DECEASED'S SPOUSE, DOMESTIC PARTNER, CHILD, PARENT/LEGAL GUARDIAN, OR THE PERSON IN CONTROL OF THE DISPOSITION AS WRITTEN ON THE DEATH CERTIFICATE MAY OBTAIN A COPY OF THE DEATH CERTIFICATE. IF FURTHER INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6), 2011 A MEDICAL EXAMINER REPORTED THAT THE VNS PATIENT HAD PASSED AWAY ON (B)(6), 2011. THE PATIENT'S BODY WAS FOUND DECOMPOSING IN A WOODED AREA SO HE SAID IT COULD BE A POSSIBLE SUICIDE BUT HE DOES NOT HAVE THE CAUSE OF DEATH AT THIS TIME. THE RETURN OF THE PATIENT'S VNS DEVICE WHEN EXPLANTED WAS REQUESTED HOWEVER IT HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. A COPY OF THE PATIENT'S AUTOPSY REPORT WAS REQUESTED FROM THE MEDICAL EXAMINER'S OFFICE BUT THEY REPORTED THAT THE PATIENT'S NEXT OF KIN CONSENT MUST BE OBTAINED BEFORE THEY CAN RELEASE AN AUTOPSY REPORT. SINCE THE MANUFACTURER DOES NOT HAVE THE NEXT OF KIN CONSENT THEN THE AUTOPSY REPORT CANNOT BE OBTAINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    CAUSE OF DEATH INFORMATION OBTAINED FROM THE NATIONAL DEATH INDEX (NDI) WAS REVIEWED BY THE MANUFACTURER WHICH INDICATED THAT THE PATIENT'S CAUSE OF DEATH WAS POTENTIAL SUICIDE, WITH UNDERLYING CAUSE AS INTENTIONAL SELF-POISONING (SUICIDE) BY AND EXPOSURE TO OTHER AND UNSPECIFIED DRUGS, MEDICAMENTS, AND BIOLOGICAL SUBSTANCES; DEATH AXIS 2 STATES POISONING BY ANTIALLERGIC AND ANTIEMETIC DRUGS; DEATH AXIS 3 STATES TOXIC EFFECT OF ETHANOL, DEATH AXIS 4 INTENTIONAL SELF-POISONING (SUICIDE) BY AND EXPOSURE TO ALCOHOL. THERE IS NO ALLEGATION OR OTHER INFORMATION INDICATING THAT THE DEATH IS RELATED TO VNS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 WHEN ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN. THE PHYSICIAN REPORTED THAT THE PATIENT'S CAUSE OF DEATH IS UNKNOWN. THE PHYSICIAN REPORTED THAT THE PATIENT ALSO HAD HODGKIN'S LYMPHOMA AT THE TIME OF HIS DEATH. THE PATIENT HAD COMPLEX PARTIAL AND 2ND GENERALIZED SEIZURES. THE PATIENT'S SISTER REPORTED TO THE PHYSICIAN THAT THE PATIENT DIED. THE PHYSICIAN DOES NOT KNOW IF THE DEATH WAS WITNESSED. THE PHYSICIAN TRIED TO CALL THE PATIENT'S SISTER TO FIND OUT THE CAUSE OF DEATH BUT WAS UNABLE TO GET THROUGH TO HER. THE PATIENT DID NOT HAVE A HISTORY OF BEING WORKED UP FOR RESECTIVE EPILEPSY SURGERY AND THE PHYSICIAN STATED THAT THE PATIENT (B)(6) VNS WAS NOT EXPLANTED. THE PHYSICIAN DID NOT KNOW IF THERE WAS A RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND VNS. THE PATIENT WAS TAKING LAMOTRIGINE, LEVIDTERAM, AND VIMPAT AT THE TIME OF HIS DEATH. ADDITIONAL INFORMATION REGARDING THE PATIENT'S CANCER HAS BEEN REQUESTED FROM THE PHYSICIAN, ESPECIALLY THE RELATIONSHIP OF THE CANCER TO VNS, BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 015709

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death