BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN CRT-D

    MDR report key: 11494792 · Received March 16, 2021

    Report

    Report Number
    2124215-2021-05999
    Event Type
    Death
    Date Received
    March 16, 2021
    Date of Event
    February 23, 2021
    Report Date
    June 14, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526534539
    PMA / PMN Number
    P010012/S341
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 0

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REMOTE MONITORING NOTIFICATION WAS TRIGGERED DUE TO DEATH OF THIS PATIENT WITH THIS DEVICE. THE LOCAL CLINIC CALLED FOR POLICE ASSISTANCE AND BOSTON SCIENTIFICS TECHNICAL SERVICES (TS) WAS CONTACTED FOR ELECTROGRAM RETRIEVAL AND REVIEW; HOWEVER, IT WAS NOTED THE PATIENT HAD ALREADY BEEN UNENROLLED IN THE LATITUDE SYSTEM AND THUS NO FURTHER INFORMATION OBTAINABLE AT THIS TIME. THE MEDICAL FACILITY INQUIRED SPECIFICALLY REGARDING THE TIME OF DEATH ELECTROGRAMS, SO AS TO SEE IF A SLOW VENTRICULAR TACHYCARDIA HAD BEEN INITIATED DUE TO BI-VENTRICULAR, PACING. THE FIELD REPRESENTATIVE CONFIRMED THE PATIENTS BODY WAS NO LONGER AVAILABLE FOR DEVICE RETRIEVAL NOR FURTHER DATA COLLECTION. FIELD FOLLOW-UP STATED THE REASON FOR THE INABILITY TO RETRIEVE THE DEVICE WAS DUE TO IT BEING LOCATED AT ANOTHER MEDICAL FACILITY AND RETRIEVAL NOT POSSIBLE DUE TO LOGISTICAL ISSUES. NO RETURN PRODUCT TESTING NOR FULL DATA REVIEW WAS REQUESTED HOWEVER, THE ONLY REQUEST AT THE TIME OF DEATH WAS A LATITUDE EPISODE REVIEW. THE PATIENT WAS CONFIRMED UNENROLLED FROM THE REMOTE MONITORING SYSTEM, SOMETIME BETWEEN THE TIME OF DEATH AND THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE, NOTIFICATION. ADDITIONALLY, IT WAS UNKNOWN IF AN AUTOPSY WAS COMPLETED AND NO ADDITIONAL INFORMATION REGARDING THE DEATH IS EXPECTED. AN IN DEPTH TS REVIEW OF THE AVAILABLE INFORMATION WAS LATER CONDUCTED. TS CONFIRMED THE LAST RECORDED EVENT HAD DATA CORRESPONDING TO THE PRESENTING ELECTROGRAM WHICH WAS COLLECTED AT THE TIME OF THE LAITUTDE INTERROGATION. IT WAS NOTED DURING THE REVIEW, THAT THE DEVICE EXHIBITED BEHAVIOR WITH NO CORRESPONDING SIGNALS ON THE SHOCK CHANNEL, INDICATIVE OF THE DEVICE ATTEMPTING TO PACE A DECEASED PATIENT. THE PREVIOUS EVENT ONE DAY PRIOR, ILLUSTRATED THE PATIENT TO BE IN A SINUS TACHYCARDIA RATE WITH THE DEVICE PERFORMING AS INTENDED. THE MORPHOLOGY OF THE SHOCK CHANNEL WAS QUITE DIFFERENT FROM PREVIOUSLY RECORDED EVENTS. BI-VENTRICULAR TRIGGER WAS ISSUED ON A PREMATURE VENTRICULAR CONTRACTION (PVC) SIGNAL WHICH WAS THEN FOLLOWED BY A SLOW POLYMORPHIC VENTRICULAR TACHYCARDIA (VT) WITH EVIDENCE OF AV DISSOCIATION. THE VT WAS DETECTED IN THE PROGRAMMED VT ZONE AND CLASSIFIED AS GRADUAL IN REGARDS TO ONSET. THIS IN TURN CAUSED THE DEVICE TO WITHHOLD THERAPY, AS EXPECTED. THE LEFT VENTRICULAR EGM MARKERS SHOW A FAST VENTRICULAR RATE WHILE THE RIGHT VENTRICULAR APPEARS TO BE SLOWER, INDICATIVE OF A POSSIBLE LEFT ORIGINATED VT. THE SHOCK CHANNEL SHOWED A COMPLEX POLYMORPHIC VT MORPHOLOGY. THE MORPHOLOGY OF THE SHOCK SIGNAL HAD SIGNIFICANTLY CHANGED OVER THE PERIOD OF THE FINAL RECORDED EPISODES. THIS INDICATED THAT THE HEART CONDITION WAS SIGNIFICANTLY ALTERED, PRIOR THE RECORDING OF THE FINAL EVENTS. OUT OF RANGE ALERTS FROM THE REMOTE MONITORING SYSTEM CORRESPONDED TO THE DATE OF DEATH. TS WAS ABLE TO CONFIRM THAT THE IMPLANTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE RATE CHANGES NOR, EXHIBITED ANY PERFORMANCE ISSUES CONTRIBUTING TO THE DEATH OR THIS PATIENT CONCLUDING, THAT THE DEVICE PERFORMED AS PROGRAMMED. THE FIELD REPRESENTATIVE STATED THEY WERE NOT MADE AWARE OF THE CAUSE OF DEATH OR IF AN AUTOPSY HAD BEEN PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REMOTE MONITORING NOTIFICATION WAS TRIGGERED DUE TO DEATH OF THIS PATIENT WITH THIS DEVICE. THE LOCAL CLINIC CALLED FOR POLICE ASSISTANCE AND BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) WAS CONTACTED FOR ELECTROGRAM RETRIEVAL AND REVIEW; HOWEVER, IT WAS NOTED THE PATIENT HAD ALREADY BEEN UNENROLLED IN THE LATITUDE SYSTEM AND THUS NO FURTHER INFORMATION OBTAINABLE AT THIS TIME. THE MEDICAL FACILITY INQUIRED SPECIFICALLY REGARDING THE TIME OF DEATH ELECTROGRAMS, SO AS TO SEE IF A SLOW VENTRICULAR TACHYCARDIA HAD BEEN INITIATED DUE TO BI-VENTRICULAR, PACING. THE FIELD REPRESENTATIVE CONFIRMED THE PATIENTS BODY WAS NO LONGER AVAILABLE FOR DEVICE RETRIEVAL NOR FURTHER DATA COLLECTION. FIELD FOLLOW-UP STATED THE REASON FOR THE INABILITY TO RETRIEVE THE DEVICE WAS DUE TO IT BEING LOCATED AT ANOTHER MEDICAL FACILITY AND RETRIEVAL NOT POSSIBLE DUE TO LOGISTICAL ISSUES. NO RETURN PRODUCT TESTING NOR FULL DATA REVIEW WAS REQUESTED HOWEVER, THE ONLY REQUEST AT THE TIME OF DEATH WAS A LATITUDE EPISODE REVIEW. THE PATIENT WAS CONFIRMED UNENROLLED FROM THE REMOTE MONITORING SYSTEM SOMETIME BETWEEN THE TIME OF DEATH AND THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE NOTIFICATION. ADDITIONALLY, IT WAS UNKNOWN IF AN AUTOPSY WAS COMPLETED AND NO ADDITIONAL INFORMATION REGARDING THE DEATH WAS EXPECTED. AN IN DEPTH TS REVIEW OF THE AVAILABLE INFORMATION WAS LATER CONDUCTED. TS CONFIRMED THE LAST RECORDED EVENT HAD DATA CORRESPONDING TO THE PRESENTING ELECTROGRAM WHICH WAS COLLECTED AT THE TIME OF THE LATITUDE INTERROGATION. IT WAS NOTED DURING THE REVIEW THAT THE DEVICE EXHIBITED BEHAVIOR WITH NO CORRESPONDING SIGNALS ON THE SHOCK CHANNEL, INDICATIVE OF THE DEVICE ATTEMPTING TO PACE A DECEASED PATIENT. THE PREVIOUS EVENT ONE DAY PRIOR, ILLUSTRATED THE PATIENT TO BE IN A SINUS TACHYCARDIA RATE WITH THE DEVICE PERFORMING AS INTENDED. THE MORPHOLOGY OF THE SHOCK CHANNEL WAS QUITE DIFFERENT FROM PREVIOUSLY RECORDED EVENTS. BI-VENTRICULAR TRIGGER WAS ISSUED ON A PREMATURE VENTRICULAR CONTRACTION (PVC) SIGNAL WHICH WAS THEN FOLLOWED BY A SLOW POLYMORPHIC VENTRICULAR TACHYCARDIA (VT) WITH EVIDENCE OF AV DISSOCIATION. THE VT WAS DETECTED IN THE PROGRAMMED VT ZONE AND CLASSIFIED AS GRADUAL IN REGARDS TO ONSET. THIS IN TURN CAUSED THE DEVICE TO WITHHOLD THERAPY, AS EXPECTED. THE LEFT VENTRICULAR EGM MARKERS SHOW A FAST VENTRICULAR RATE WHILE THE RIGHT VENTRICULAR APPEARS TO BE SLOWER, INDICATIVE OF A POSSIBLE LEFT ORIGINATED VT. THE SHOCK CHANNEL SHOWED A COMPLEX POLYMORPHIC VT MORPHOLOGY. THE MORPHOLOGY OF THE SHOCK SIGNAL HAD SIGNIFICANTLY CHANGED OVER THE PERIOD OF THE FINAL RECORDED EPISODES. THIS INDICATED THAT THE HEART CONDITION WAS SIGNIFICANTLY ALTERED, PRIOR TO THE RECORDING OF THE FINAL EVENTS. OUT OF RANGE ALERTS FROM THE REMOTE MONITORING SYSTEM CORRESPONDED TO THE DATE OF DEATH. TS WAS ABLE TO CONFIRM THAT THE IMPLANTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE RATE CHANGES NOR, EXHIBITED ANY PERFORMANCE ISSUES CONTRIBUTING TO THE DEATH OR THIS PATIENT CONCLUDING, THAT THE DEVICE PERFORMED AS PROGRAMMED. THE FIELD REPRESENTATIVE STATED THEY WERE NOT MADE AWARE OF THE CAUSE OF DEATH OR IF AN AUTOPSY HAD BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REMOTE MONITORING NOTIFICATION WAS TRIGGERED DUE TO DEATH OF THIS PATIENT WITH THIS DEVICE. THE LOCAL CLINIC CALLED FOR POLICE ASSISTANCE AND BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) WAS CONTACTED FOR ELECTROGRAM RETRIEVAL AND REVIEW; HOWEVER, IT WAS NOTED THE PATIENT HAD ALREADY BEEN UNENROLLED IN THE LATITUDE SYSTEM AND THUS NO FURTHER INFORMATION OBTAINABLE, AT THIS TIME. THE MEDICAL FACILITY INQUIRED SPECIFICALLY REGARDING THE TIME OF DEATH ELECTROGRAMS, SO AS TO SEE IF A SLOW VENTRICULAR TACHYCARDIA HAD BEEN INITIATED DUE TO BI-VENTRICULAR, PACING. THE FIELD REPRESENTATIVE CONFIRMED THE PATIENTS BODY WAS NO LONGER AVAILABLE FOR DEVICE RETRIEVAL NOR FURTHER DATA COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391344 INOGEN CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION G140 482839 00802526534539

    Patients

    Seq Age Sex Outcome Treatment
    1 Death