BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVIVE

    MDR report key: 8275894 · Received January 24, 2019

    Report

    Report Number
    2124215-2019-00883
    Event Type
    Death
    Date Received
    January 24, 2019
    Date of Event
    December 25, 2018
    Report Date
    January 24, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NKE
    UDI-DI
    00802526536632
    PMA / PMN Number
    P030005/S079
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS "REPORT" THAT THIS HEALTH CARE PROFESSIONAL CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES. THE CONSULTANT WAS INFORMED THAT THIS PATIENT HAD DIED ON (B)(6) 2018. A REVIEW OF THE EPISODE FOUND THAT THE VENTRICULAR TACHYCARDIA APPEARS JUST PRIOR TO AN AUTOMATIC CAPTURE TEST. A SUCCESSFUL RIGHT VENTRICULAR AUTOMATIC THRESHOLD (RVAT-1704) OCCURRED ON (B)(6) 2018 AT 0356. THE NEXT SCHEDULED TEST SHOULD HAVE OCCURRED AT 0056 ON (B)(6) 2018. THE COMPLETION OF THE EPISODE COULD NOT BE VIEWED. THE DEVICE RATE SMOOTHING FEATURE IS PROGRAMMED ON. IN THE LONG VT EPISODE AT 0056 ON (B)(6) 2018, A CAPTURE OUTPUT VOLTAGE INDICATES THAT THE TEST HAD ALREADY STARTED. THE RHYTHM TERMINATED FOLLOWING A SHORT RUN OF VT. THIS WAS FOLLOWED BY THREE 1.0 VOLT THRESHOLD MARKERS AND A FEW BEATS OF VT. TWO 0.9 VOLT THRESHOLD MARKERS OCCURRED WITH RATE SMOOTHING. THERE IS ONE BEAT OF FUNCTIONAL UNDERSENSING AP-BIV PACING WHICH IS THEN FOLLOWED BY VT. THE CONSULTANT COULD NOT RULE OUT THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTE TO THE VT AS THE LAST EVENT COULD HAVE BEEN AN R-ON-T. THE VT CYCLE LENGTH IS VERY FAST (250-300 MS) ASSOCIATED WITH VA DISSOCIATION AND APPEARED TO BE RIGHT-SIDED. THE INTERMITTENT RVAT ATTEMPTS ARE DUE TO RHYTHM TERMINATION. RATE SMOOTHING FORCED FASTER PACING WITH SOME EVIDENCE OF TACHYCARDIA UNDERSENSING. LEAD DIAGNOSTICS APPEARED ACCEPTABLE AND WERE WITHIN NORMAL LIMITS. THE VT FROM EPISODE# V-16 LASTED FOR 10 MINUTE 32 SECONDS. THERE WERE FOUR MORE EPISODES ON (B)(6) 2018 AT 0107, 0108, 0109 AND 0111. NO ELECTROGRAMS WERE AVAILABLE FOR REVIEW FOR EPISODE# V-17 AT 0107. THE OTHER THREE EPISODES HAD ELECTROGRAMS. THE AVERAGE HEART RATES FOR ALL FIVE EPISODES WERE 232, 205, 183, 182 AND 152 BPM. THE CONSULTANT BRIEFLY REVIEWED THE MORE RECENT EPISODES WHICH SHOWED EVIDENCE OF UNDERSENSING, FUNCTIONAL UNDERSENSING (DUE TO TRIGGER PACING AND RATE SMOOTHING) AND NORMAL SENSED VT. FURTHER ANALYSIS FOUND THAT THE MOST RECENT DAILY RECORDED MEASUREMENT WAS ON (B)(6) 2018 AT 0356 FOR 0.8 VOLTS. THE MOST RECENT RECORDED MEASUREMENT WAS TAKEN ON (B)(6) 2018 AT 0251 AND WAS AN EVOKED RESPONSE FOR LESS THAN A MINUTE. BASED ON REVIEW OF THE PRINTOUT FROM EPISODE#16, PRODUCT INVOLVEMENT COULD NOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66336 INVIVE PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) NKE BOSTON SCIENTIFIC CORPORATION V173 00802526536632

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| L