Description of Event or Problem · 0
THE FAMILY IS PROVIDING INFORMATION TO UPDATE MDR REPORT #3004209178-2023-02414. THIS DEVICE (MEDTRONIC VIVA QUAD XT CRT-D, WAS EXPLANTED FOLLOWING A SUDDEN DEATH ((B)(6) 2022) AND IS SUBJECT TO A CLASS I RECALL FOR LITHIUM-PLATING¿RELATED BATTERY DEPLETION (Z-1306-2021). THIS DTBA1Q1 MODEL IS ALSO SUBJECT TO TWO CLASS I RECALLS FOR HIGH-VOLTAGE FAILURE MECHANISMS (Z-0584-2018 INTERNAL HIGH-VOLTAGE ARCING; FDA EVENT 1080837 GLASSED FEEDTHROUGH). THIS IS A BLACKWELL DEVICE, SUBJECT TO 2018 FDA MANUFACTURING VIOLATIONS INVOLVING HIGH-VOLTAGE CIRCUITRY. THE FAMILY HAS REQUESTED DATA EXTRACTION + RECALL-SPECIFIC ANALYSIS TO EVALUATE BOTH HIGH-VOLTAGE AND BATTERY FUNCTION IN LIGHT OF THE RECALLS AND FOLLOWING INFORMATION: ON THE DAY OF DEATH, EMS DOCUMENTED THE PATIENT IN VF/VT AND MANUALLY SHOCKED HIM TWICE. THE DEVICE WAS NOT OBSERVED TO HAVE SHOCKED THE PATIENT. THE DEVICE WAS EXPLANTED BY A FORENSIC PATHOLOGIST THREE DAYS POST-MORTEM, WHO IDENTIFIED NO ACUTE HEART ATTACK OR STROKE. THE EVENT DATE IS THE DAY OF DEATH, (B)(6) 2022; THE CURRENT MDR HAS IT LISTED AS 10/21/21. THE EXPLANT DATE ALSO NEEDS TO BE CORRECTED IN MEDTRONIC'S RECORDS; THE DEVICE WAS EXPLANTED ON (B)(6) 2022, NOT (B)(6) 2022. THE CURRENT MDR REPORTS PREVIOUS DEVICE INTERROGATIONS SHOWED NORMAL DEVICE FUNCTION. HOWEVER, RECORDS FROM (B)(6) 2021 AND (B)(6) 2021 SHOW LV CAPTURE MANAGEMENT DETERMINED THAT THE LV THRESHOLD INCREASED AND EXCEEDED THE AMPLITUDE SAFETY MARGIN. A HANDWRITTEN NOTE ON THE (B)(6) 2021 INTERROGATION DOCUMENTED "CHRONIC LV THRESHOLD" WITH UPWARD ARROW NOTATION. IN (B)(6) 2022, MEDICAL RECORDS SHOW THE PATIENT'S EF HAD DECLINED APPROXIMATELY 13 POINTS IN ONE YEAR, TO A LEVEL SIMILAR TO EF IN 2015 MEDICAL RECORDS PRIOR TO CRT-D IMPLANTATION. THE RAPID DECLINE RAISES QUESTIONS ABOUT WHETHER THE DEVICE WAS DELIVERING EFFECTIVE CRT PACING. THE CURRENT MDR REPORTS REMAINING BATTERY LONGEVITY OF FOUR MONTHS ONE MONTH PRIOR TO DEATH; IN A STANDARD DEVICE, THIS ESTIMATE WOULD PLACE THE DEVICE APPROXIMATELY ONE MONTH FROM THE 3-MONTH RRT THRESHOLD. HOWEVER, THIS DEVICE WAS SUBJECT TO A CLASS I LITHIUM-PLATING RECALL, WHICH WARNED OF UNPREDICTABLE, ACCELERATED DEPLETION THAT CAN SIGNIFICANTLY SHORTEN THE EXPECTED TIMEFRAME BETWEEN RRT AND EOL AND MAY MANIFEST AS AN UNEXPECTED CHANGE IN THE REMAINING LONGEVITY ESTIMATE. IN THIS CONTEXT, THE (B)(6) 2022 "FOUR-MONTH" ESTIMATE IS MOST RELEVANT BECAUSE IT PLACED THE DEVICE CLOSE TO THE RRT THRESHOLD IN THE MONTH LEADING UP TO DEATH, IN A RECALL WHERE RRT-TO-EOL TIMING AND LONGEVITY ESTIMATES MAY CHANGE UNEXPECTEDLY. IN (B)(6) 2022, THE NEXT DEVICE CHECK APPOINTMENT WAS SCHEDULED FOR (B)(6) 2022. ONE MONTH AFTER THE FOUR-MONTH ESTIMATE, ON (B)(6) 2022, THE PATIENT WAS SEEN IN CLINIC WITH HIS WIFE IN ATTENDANCE; THE PROVIDER NOTE DOCUMENTED MULTIPLE BATTERY CONCERNS AND WROTE, "SINCE LAST BEING SEEN, HIS PACER IS NOW AT EBL." THE PATIENT DIED SUDDENLY THE FOLLOWING DAY. THE PATIENT WAS NOT ON HOME MONITORING AND WAS NEVER INFORMED OF THE RECALL INITIATED THE PRIOR YEAR. THE PATIENT AND HIS WIFE UNDERSTOOD THAT DEVICE REPLACEMENT WAS EXPECTED TO BE SCHEDULED IN (B)(6) 2022 AND DISCUSSED THIS THE DAY BEFORE DEATH WITH THE PROVIDER. THE DEVICE WAS RETURNED FOR ANALYSIS, AND EVALUATION WAS PAUSED PRIOR TO DESTRUCTIVE TESTING. MANUFACTURER'S INITIAL ANALYSIS REPORTED THE DEVICE HAD NO TELEMETRY, A FINDING THAT ALIGNS WITH KNOWN FAILURE MODES OF THE LITHIUM-PLATING RECALL IMPACTING THIS DEVICE. MANUFACTURER'S INITIAL VISUAL ANALYSIS IDENTIFIED SELECTIVE DAMAGE: THE RA AND RV LEADS WERE BREACHED WITH BLOOD INGRESS, AND ALL HIGH-VOLTAGE GROMMETS (HVB, HVX, RA, RV) WERE DAMAGED, WITH FOREIGN MATERIAL IDENTIFIED IN THE RV PORT. IN CONTRAST, THE LV LEAD AND LV GROMMET WERE FOUND TO BE UNDAMAGED AND FREE OF INGRESS. A DATA EXTRACTION, DETAILED VISUAL INSPECTION, + FORENSIC RECALL-SPECIFIC FAILURE ANALYSIS ARE FORMALLY BEING REQUESTED.