Description of Event or Problem · 1
IT WAS REPORTED THAT THIS VNS PATIENT DIED ON (B)(6) 2013. THE PATIENT WAS IMPLANTED ON (B)(6) 2013, AND SURGERY WENT WELL. THE NEXT DAY, THE PATIENT HAD A FEVER AND BREATHING ISSUES. THE FAMILY CALLED AN AMBULANCE, AND THE EMTS ATTEMPTED TO RESUSCITATE THE PATIENT BUT WERE NOT ABLE TO. THE CAUSE OF DEATH WAS UNKNOWN. THE DEVICE WAS NOT EXPLANTED. THE DEVICE WAS NOT PROGRAMMED ON AT THE TIME OF SURGERY. THE SURGEON AND NEUROLOGIST DID NOT THINK THAT THE DEATH WAS RELATED TO VNS. THE PHYSICIAN STATED THAT THE PATIENT WAS DECLINING IN HEALTH FOR OVER A YEAR. FOLLOW-UP WITH THE PATIENT'S NEUROLOGIST SHOWED THAT THE CAUSE OF DEATH WAS CARDIOPULMONARY ARREST AND PROBABLY SUDEP. THE RELATIONSHIP OF THE PATIENT'S DEATH TO VNS THERAPY OR SURGERY WAS UNDETERMINED. THE PATIENT DID EXHIBIT RISK FACTORS THAT WOULD MAKE HIM MORE SUSCEPTIBLE TO SUDEP. A DEATH FORM FROM THE PHYSICIAN INDICATED THAT THE PATIENT'S CONCURRENT ILLNESS WAS A CHROMOSOME 2 DELETION AND ENCEPHALOPATHY WITH GLOBAL DELAY/REGRESSION. NO AUTOPSY WAS PERFORMED. THE DEATH WAS WITNESSED BY THE PATIENT'S MOTHER AND DID NOT RESULT FROM TRAUMA. THE PATIENT WAS FOUND PULSELESS, NOT BREATHING, AND UNRESPONSIVE. CPR WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE PATIENT WAS AGE ONE AT THE ONSET OF EPILEPSY. THE PATIENT HAD A HISTORY OF NOCTURNAL AND FEBRILE SEIZURES. THE PATIENT'S SEIZURE TYPES AND FREQUENCY (PER MONTH) WERE PROVIDED: SIMPLE PARTIAL: 30+, 2ND GENERALIZED: 50+, COMPLEX PARTIAL: 30+, GTC: 15. THE PATIENT HAD A HISTORY OF RESPIRATORY SUPPRESSION WITH ILLNESS/INCREASED SEIZURES. FOLLOW-UP WITH THE SURGEON SHOWED THAT THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO COMPLICATIONS AND THAT INTRAOPERATIVE IMPEDANCE WAS WITHIN NORMAL LIMITS AN IN-HOUSE SUDEP EVALUATION CONCLUDED THE DEATH WAS POSSIBLE SUDEP. THE PATIENT WAS FOUND PULSELESS AND UNRESPONSIVE. THE PATIENT HAS SUDEP RISK FACTORS OF FEBRILE AND NOCTURNAL SEIZURES.