BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIVE

    MDR report key: 9550698 · Received January 6, 2020

    Report

    Report Number
    2124215-2019-27125
    Event Type
    Injury
    Date Received
    January 6, 2020
    Date of Event
    November 14, 2019
    Report Date
    April 27, 2020
    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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY REVIEW OF THE THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER'S (CRT-P'S) MEMORY FOUND IT HAD NEVER TRIGGERED THE REPLACEMENT INDICATOR WHILE IMPLANTED. FURTHER REVIEW NOTED THAT THERE WAS A TOTAL OF NINE POWER ON RESETS THAT OCCURRED WITHIN A THREE MONTH TIME FRAME. THE FINAL RESET WAS DUE TO THREE POWER ON RESETS WHICH PUT THE DEVICE INTO SAFETY MODE. THE CRT-P PASSED LONGEVITY CALCULATIONS. THE DEVICE WAS PUT BACK INTO PRIMARY OPERATION TO COMPLETE FURTHER TESTING, HOWEVER IT WAS UNABLE TO COMPLETE AS THE DEVICE REVERTED BACK TO SAFETY MODE WHILE THE TEST WAS RUNNING DUE TO POWER ON RESETS. THE DEVICE PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS OF THE DEVICE COMMENSURATE WITH BATTERY VOLTAGE. THE DEVICE CASE WAS OPENED AND A BATTERY VOLTAGE OF 2.792V WAS NOTED. THE BATTERY WAS REMOVED AND THE CURRENT DRAIN WAS WITHIN TOLERANCE OF THE CIRCUIT. FURTHER DETAILED ANALYSIS DETERMINED THE CAUSE OF THE CRT-P GOING INTO SAFETY MODE WAS DUE TO A SHORTED BATTERY. THE BATTERY WAS SHORTED DUE TO A TUBE TEAR.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED TO SUBMIT THE ANALYSIS RESULTS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SHOWED NINE MONTHS REMAINING AND THEN TWO MONTHS LATER SHOWED IT WAS IN SAFETY MODE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED PACING WILL REMAIN, BUT WITH NO LEFT VENTRICULAR (LV) OFFSET AND BOTH RIGHT VENTRICULAR (RV) LEAD AND LV ARE UNIPOLAR CONFIGURATION. THE CRT-P WAS EXPLANTED AND REPLACED THE FOLLOWING DAY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15881 INVIVE IMPLANTABLE PACEMAKER NKE BOSTON SCIENTIFIC CORPORATION V173 100394 00802526536632

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R