Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PATIENT HAD A CARDIAC ISSUES DURING A GENERATOR REPLACEMENT SURGERY ON (B)(6) 2016. HOWEVER, DUE TO THESE CARDIAC ISSUES, THE GENERATOR COULD NOT BE REPLACED; IT WAS SWITCHED OFF AT THAT TIME. IT WAS REPORTED BY A NURSE THAT THE PATIENT, WHO HAS TUBEROUS SCLEROSIS, HAD CARDIAC RHABDO WHICH WERE SHOWN TO BE REGRESSING AT THE LAST FOLLOW-UP IN 2011. THE NURSE REPORTED THAT THE PATIENT WAS IMPLANTED WITH VNS IN 2013 WITHOUT PROBLEMS. THE SYSTEM DIAGNOSTICS TEST SHOWED NO ISSUES AT THAT TIME. IT WAS NOTED HOWEVER THAT THE PATIENT HAD THE ODD ECTOPIC, BUT NOTHING OF ANY WORRY. DURING THE SURGERY ON (B)(6) 2016, THE PATIENT DEVELOPED BRIEF RUNS OF VENTRICULAR TACHYCARDIA (VT) UNDER GENERAL ANESTHETICS. THE NURSE THEN TURNED THE VNS OFF. THE VT BECAME PROLONGED AND SUSTAINED AT TIMES SO THE ANESTHETIST CALLED A HALT TO THE SURGERY. THERE WAS A SINUS RHYTHM BETWEEN THESE RUNS. BLOOD PRESSURE AND PULSE MAINTAINED THROUGHOUT THE SURGERY. THE CARDIOLOGIST WAS CALLED TO THE THEATRE AND THE DEFIBRILLATION MATERIAL WAS PREPARED, BUT WAS NOT USED. THE NURSE TURNED THE VNS ON AGAIN WHEN THE PATIENT WAS ATTACHED TO A 12 LEAD ECG (VNS WAS PROGRAMMED AT 1MA OUTPUT CURRENT / 20SEC ON TIME / 1.5MIN OFF TIME), BUT NO CHANGES WERE NOTED ON THE ECG. VNS WAS THEN TURNED OFF AGAIN AND THE SURGERY WAS CANCELLED SO THAT CARDIOLOGY COULD REVIEW THE PATIENT. THE PATIENT CONTINUED TO HAVE RUNS OF VT, BUT NOT AS SEVERE AS WHEN HE WAS UNDER GENERAL ANESTHETICS. AN ECHO WAS PERFORMED WHICH SHOWED NO LARGE TUMORS, BUT LOTS OF SCARRING WHICH COULD LEAD TO DYSRHYTHMIAS. PATIENT HAS BEEN PUTTED ON BETA BLOCKERS AT THAT TIME. IT WAS REPORTED THAT THE ANESTHETIST BELIEVED THE VOLATILE AGENTS OF THE GENERAL ANESTHETICS CAUSED THESE EVENTS. ADDITIONAL INFORMATION WAS RECEIVED LATER, FROM THE NURSE, INDICATING THAT THE EVENT WAS SOLVED WITH CARDIAC DRUGS ON WHICH THE PATIENT CONTINUES. IT WAS REPORTED THAT THE EVENT WAS RELATED TO SCAR TISSUE IN HIS HEART. IT WAS REPORTED THAT THE DEVICE WAS INITIALLY GOING TO BE REPLACED TO DUE TO IFI. ACCORDING TO THE NURSE, THE PARENTS DO FEEL THAT THERE HAS BEEN A BENEFIT WITH VNS THERAPY AND OVER THE TIME THE VNS WAS SWITCHED OFF THE SEIZURES CREPT UP ALSO, AS BATTERY WAS DRAINING SEIZURE FREQUENCY INCREASED. THE PARENTS WISH TO PROCEED WITH BATTERY CHANGE. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT BOTH, THE GENERATOR AND THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.