Description of Event or Problem · 1
THIS REPORT IS REGARDING THE RECENT GUIDANT PACEMAKER RECALLS AND SPECIFICALLY THE PULSAR MAX II MODELS -OF WHICH THE 2800 WAS MISSING AND DUE TO MY EXPERIENCE WITH IT. I BELIEVE IS A DEFECTIVE PRODUCT-. IN 2002, THE RETROMAMMARY POCKET AND THE INFRACLAVICULAR SCAR FROM PREVIOUS LEAD SURGERIES, WERE OPENED. AN ATRIAL LEAD WAS TUNNELED FROM THE INFRACLAVICULAR POCKET TO THE INFRAMMARY POCKET. THE CHRONICALLY IMPLANTED VENTRICULAR LEAD AND ACUTELY IMPLANTED ATRIAL LEAD WERE ATTACHED TO A NEW GUIDANT PULSAR MAX II MODEL # 1280, PULSE GENERATOR -DUAL CHAMBER-. I REMAINED IN THE HOSP FOR APPROX FIVE DAYS POSTOPERATIVELY. ON THE SECOND POST-OP DAY, THERE WAS NOTICEABLE EDEMA IN THE LEFT ARM ALTHOUGH PULSES WERE PALPABLE AND THERE WAS NO DISCOLORATION. ON THE DAY OF DISCHARGE I DEVELOPED A FEVER AND GENERAL EDEMA THROUGHOUT MY UPPER AND LOWER EXTREMITIES AND IN THE ABDOMEN. I WAS STARTED ON LEVOFLOXACIN AND INCREASED THE MAXZIDE DOSAGE FOR DIURESIS. POSTOPERATIVELY, I DID WELL WITH OCCASIONAL RUNS OF SINUS TACHYCARDIA AND PACEMAKER INDUCED WENCKEBACH WHICH WAS TERMINATED WITH REPROGRAMMING. APPROX THE THIRD WEEK POST-OP, I BEGAN HAVING FREQUENT RUNS OF ECTOPIC ATRIAL TACHYCARDIA WITH RATES FROM 160-290, DOCUMENTED VIA THE ARRHYTHMIA LOG BOOK WITHIN THE PULSE GENERATOR. MULTIPLE ATRS WERE DOCUMENTED. DESPITE MULTIPLE REPROGRAMMING ATTEMTPS, I EXPERIENCED PROGRESSIVELY WORSE DIZZINESS, PALLOR AND WOULD BECOME COOL AND CLAMMY. A MO AFTER IMPLANT, I EXPERIENCED A PRESYNCOPAL EPISODE AND COLLASPED WHILE CALLING MY BROTHER FOR HELP. I WAS FOUND ON THE FLOOR IN OUR HOME BY THE PARAMEDICS AND WAS TAKEN TO THE HOSP WHERE I WAS ADMITTED TO TELEMETRY. NADOLOL WAS STARTED TO SUPPRESS THE ATRIAL RATE. DURING THAT HOSPITALIZATION, A FOLLOW-UP ECHO WAS PERFORMED WHICH SHOWED MARKEDLY ENLARGED RIGHT ATRIUM, MODERATELY ENLARGED RIGHT VENTRICLE, GOOD RV SYSTOLIC FUNCTION, WORSENING PULMONARY HYPERTENSION, SEVERE TR; HOWEVER, THE TRICUSPID REGURGITATION SEVERITY AND GRADIENT HAD ONLY MILDLY INCREASED. THE FAILURE SYMPTOMS HAD SIGINIFICANTLY WORSENED, THOUGH THE VALVE HAD NOT. THE FOLLOWING WEEK, A RIGHT HEART CATHETERIZATION WAS PERFORMED WHICH SHOWED A CARDIAC OUTPUT OF 2.7, CARDIAC INDEX 1.7, NORMAL TO BORDERLINE RIGHT SIDED FILLING PRESSURES. OVER THE NEXT FEW MONTHS, I GRADUALLY IMPROVED WITH HIGHER DOSES OF BETA BLOCKERS AND DIURTETICS. EIGHT MOS AFTER IMPLANT, I HAD SEVERAL EPISODE OF SEVERE RAPID HEART RATES W/REPROGRAMMING ATTEMPTS. I RAPIDLY DETERIORATED WITH SYMPTOMS OF PROGRESSIVE HEART FAILURE WHICH PHYSICIANS COULD NOT UNDERSTAND AS MY TRICUSPID VALVE WAS NOT APPRECIABLY WORSE ON ECHOCARDIOGRAM. SYMPTOMS WERE CONSISTENTLY RELATED TO PACING AND ARRHYTHMIA ISSUES. THERE WERE EPISODES OF PACING AT MAX SENSOR RATE WHICH CAUSED FREQUENT MODE SWITCHING AND NEED FOR REPROGRAMMING. THERE WERE MULTIPLE OCCASIONS OF SOME TYPE OF ELECTRICAL INTERFERENCE OR CIRCUITRY NOISE THAT GUIDANT TECH SUPPORT COULD NOT EXPLAIN -ALTHOUGH CONSIDERING THAT I BECAME SEVERELY SYMPTOMATIC WITH THESE EPISODES, THEY OFFERED TO PROVIDE A REPLACEMENT DEVICE CONSIDERING MY LEVEL OF PACEMAKER DEPENDENCE. GIVEN RISKS OF SURGERY AND OPENING POCKET, MY PHYSICIAN'S RECOMMENDATION WAS TO WAIT AND EVALUATE FURTHER. I ALSO HAD EXPERIENCED SEVERE AND PAINFUL GRATING AROUND THE GENERATOR WHICH WAS UNEXPLAINED. ON ONE OCCASION, DURING AN INTERROGATION, THE PROGRAMMER RECEIVED SOME TYPE OF UNIDENTIFIED WARNING FROM MY GENERATOR AND THEN BLANKED OUT, IMMEDIATELY CHANGING ALL OF MY PROGRAMMING PARAMETERS TO EXTREMELY LOW, OUT OF BOX SETTINGS. I BECAME PRESYNCOPAL. I HAD SEVERAL SYNCOPAL EPISODES W/ATRIAL TACHYCARDIA AND CONTINUED TO HAVE PROBLEMS WHENEVER ACCELEROMETER CHANGES WERE MADE AND CONTINUED TO DETERIORATE W/PROGRESSIVE HEART FAILURE. DURING THE COURSE OF THIS SPRING TIME, I UNDERWENT AND AV NODAL ABLATION TO ATTEMPT TO CURTAIL THE ARRHYTHMIAS BUT THIS DID NOT MAKE A SIGNIFICANT IMPROVEMENT BEYOND A FEW WEEKS. IN 2003, I UNDERWENT A CARDIAC CATHETERIZATION ONCE AGAIN AND I WAS AT THAT POINT IN SEVERE RIGHT-SIDED HEART FAILURE, BUT AGAIN, MY TRICUSPID VALVE HAD NOT APPRECIABLY WORSENED.THE HEART FAILURE AND CHAMBER SIZES WERE DISPROPORTIONATE TO THE VALVE ISSUES. PHYSICIANS COULD NOT UNDERSTAND WHAT WAS INSTIGATING THIS PROGRESSIVE FAILURE, ALTHOUGH EACH SIGNIFICANT TURN FOR THE WORSE WAS ASSOCIATED WITH SOME PACING/TACHYCARDIA EVENT. IN 703, AT URGING OF PHYSICIANS, I UNDERWENT A COMPLEX OPEN HEART SURGICAL PROCEDURE WHICH INCLUDED REPLACEMENT OF MY TRICUSPID VALVE, EXTRACTION OF ATRIAL AND VENTRICULAR LEADS ON THE FIRST DAY. I WAS KEPT ANESTHETIZED AND ON LIFE SUPPORT -WITH ONLY A TEMPORARY PACING LINE INITIATING MY HEART BEAT- AND TAKEN FOR A SECOND DAY OF SURGERY IN WHICH A NEW PACEMAKER, ATRIAL LEAD, VENTRICULAR LEAD AND BACK UP EPICARDIAL PACING WIRES WERE IMPLANTED. THE RECOVERY WAS DIFFICULT AND COMPLICATED BY A PERICARDIAL EFFUSION OVER THE LEFT VENTRICLE BUT WITH TIME, I HEALED. UNFORTUNATELY, HOWEVER, BECAUSE BIOPROSTHETIC VALVES DO NOT TYPICALLY LAST LONGER THAN 7-9 YEARS -ON AVERAGE-, AND BECAUSE I HAVE A TRANSVENOUS LEAD PASSING THROUGH THE VALVE -CREATING SOME TR AND DAMAGE-, I AM SUBJECT TO OPEN HEART SURGERY MULTIPLE TIMES DURING THE COURSE OF MY LIFE. AS I LEARNED THIS WEEK, PACEMAKER THAT I HAD IN 2003 WAS NOT ONLY RECALLED BY FDA AND GUIDANT FOR THE SYMPTOMS THAT LED TO THIS TRAUMA AND MY LONG-TERM FATE BUT WAS INITIALLY RECALLED IN JUNE 2003 AND I WAS NEVER NOTIFIED OF THIS. I BELIEVE THE PACEMAKER CAUSED OR CONTRIBUTED TO THIS TRAUMA AND BY REMOVING IT AT THAT TIME, COULD THIS HAVE SAVED ME THIS HARM AND THE TRAUMA I FACE FOR THE REMAINDER OF MY LIFE IN DEALING WITH BIOPROSTHETIC DEVICES? THIS PARTICULAR MODEL WAS OMITTED IN THE RECENT RECALL LAST WEEK AND I EXPERIENCED VIRTUALLY EVERY MALFUNCTION REPORTED WITH THE OTHERS IN THAT FAMILY OF PACEMAKERS. PTS WHO HAVE THIS MODEL SHOULD BE NOTIFIED AND A RECALL OF THIS DEVICE INITIATED TO PREVENT SITUATIONS SUCH AS MY RECENT EXPERIENCE THAT WAS LIFE THREATENING.