BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 4180380 · Received October 17, 2014

    Report

    Report Number
    1644487-2014-02733
    Event Type
    Death
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 23, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING AND DEVICE DIAGNOSTIC HISTORY WAS PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE COUNTY MEDICAL EXAMINER WHERE IT WAS REPORTED THAT THE GENERATOR WAS REMOVED AND DISCARDED. NO AUTOPSY WAS PERFORMED AND THAT THE CAUSE OF DEATH WAS DETERMINED TO BE PROBABLE STATUS EPILEPTICUS. THERE WAS NO PHYSICAL EVIDENCE OF STATUS OR A SEIZURE. THE PATIENT WAS LAST KNOWN TO BE ALIVE BY HER NEIGHBOR ON (B)(6) 2014. AT THAT TIME, SHE SEEMED FINE AND HAD NO COMPLAINTS ABOUT HER HEALTH. ON (B)(6) 2014, THE SHERIFF¿S DEPARTMENT WAS CONTACTED FOR A WELL-BEING CHECK BECAUSE THE PATIENT¿S NEIGHBORS COMPLAINED OF AN ODOR ORIGINATING FROM THE PATIENT¿S APARTMENT. THE SHERIFF DEPUTY ENTERED THE APARTMENT AND FOUND THE PATIENT DECEASED, LYING FACE DOWN IN BED WITH OBVIOUS DECOMPOSITIONAL CHANGES. THE CORONER WAS THEN CALLED TO THE SCENE. HE FOUND THE PATIENT LYING PRONE ON THE LEFT SIDE OF A BED WITH THE BEDCOVERS PULLED UP TO HER MID-BACK. HER HEAD WAS STRAIGHT WITH HER FACE DOWN INTO THE MATTRESS AND HER AIRWAY APPEARED TO BE COMPROMISED. HER BODY EXHIBITED SIGNIFICANT DECOMPOSITION. NO PETECHIAL HEMORRHAGES, TRAUMA OR MEDICAL THERAPY WAS NOTED. NO ABUSE OF MEDICATION OR OTHER DRUGS WAS SUSPECTED. THE DECEDENT'S MEDICAL HISTORY CONSISTED OF EPILEPTIC SEIZURES (GRAND MAL TYPE) WHICH BEGAN AT AGE (B)(6). SHE STATED THAT THE SEIZURES WERE NON-TRAUMA RELATED. THE DECEDENT BEGAN HAVING MORE SEIZURES AS SHE GOT OLDER AND SHE HAD A VAGAL NERVE STIMULATOR IMPLANTED UNDER HER LEFT ARM APPROXIMATELY 5 YEARS AGO TO HELP DECREASE HER SEIZURE ACTIVITY. TO HER KNOWLEDGE, THE DECEDENT TOOK HER SEIZURE MEDICATION AS DIRECTED. THE DECEDENT WAS NOT KNOWN TO DRINK ALCOHOL, SMOKE CIGARETTES, OR USE DRUGS. PER THE PATIENT¿S NEUROLOGIST, THE PATIENT¿S MEDICAL HISTORY CONSISTED OF POORLY CONTROLLED EPILEPSY, OSTEOPENIA, PSYCHOSIS, AND UNDIAGNOSED PSYCHOLOGICAL PROBLEMS WHICH CAUSED DELUSIONS. ACCORDING TO DR. (B)(6), THE DECEDENT TOLD HIM THAT SHE WOULD BLACK OUT FOR HOURS AFTER HAVING A SEIZURE BUT SHE WAS A POOR HISTORIAN AND COULD NOT PROVIDE THE FREQUENCY OF HER SEIZURES. SHE REFUSED TO KEEP A JOURNAL OF HER SEIZURE ACTIVITY. HER LAST EEG WAS PERFORMED IN (B)(6) 2013 AND IT WAS NORMAL. HE STATED THAT THE DECEDENT WAS NOT KNOWN TO SMOKE CIGARETTES, DRINK ALCOHOL, OR USE DRUGS. THE CASE WAS REVIEWED WITH THE CHIEF MEDICAL EXAMINER AND HE ELECTED TO ISSUE THE DECEDENT'S DEATH CERTIFICATE BASED ON THE INVESTIGATION. HE DETERMINED THE CAUSE OF DEATH TO BE PROBABLE STATUS EPILEPTICUS DUE TO EPILEPSY (SEIZURE DISORDER NON-TRAUMATIC ETIOLOGY). THE MANNER OF DEATH WAS NATURAL. AN INTERNAL SUDEP EVALUATION DETERMINED THAT THE DEATH WAS PROBABLE SUDEP. THE AVAILABLE PROGRAMMING HISTORY FROM THE PATIENT¿S PULSE GENERATOR WAS REVIEWED AND THE PATIENT¿S GENERATOR WAS PROGRAMMED TO 1/25/500/21/0.5/1.5/500/60 ON (B)(6) 2014, POTENTIALLY THE FINAL OFFICE VISIT PRIOR TO DEATH. DIAGNOSTIC TESTING ON THAT DATE YIELDED NORMAL RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. THE MEDICAL EXAMINER INDICATED THAT THE PATIENT WAS FOUND DECEASED ON (B)(6) 2014 IN A STATE OF ADVANCED DECOMPOSITION SO THE TIME OF DEATH WAS INDETERMINATE. IT WAS REPORTED THT THE FINAL CAUSE OF DEATH WAS NOT YET DETERMINED, BUT THAT THE DEATH APPEARS TO BE A TERMINAL SEIZURE EVENT. THE RELATIONSHIP OF THE DEATH TO VNS IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663056 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202275

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death