BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 8006187 · Received October 25, 2018

    Report

    Report Number
    2124215-2018-60066
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    November 1, 2017
    Report Date
    March 16, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWW
    UDI-DI
    00802526496059
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO THIS EVENT IS CURRENTLY ONGOING.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    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 THIS PACEMAKER OVERSENSED NOISE RESULTING IN PACING INHIBITION WITH ASYSTOLE FOR MORE THAN TWO SECONDS. THE PATIENT IS PACEMAKER DEPENDENT PATIENT AND WAS SYNCOPAL. THE PATIENT WAS PRESCRIBED A HOLTER MONITOR WHICH CONFIRMED FREQUENT INSTANCES OF NOISE WITH PACING INHIBITION. ISOMETRICS AND POCKET MANIPULATION WERE SUCCESSFULLY IN RECREATING NOISE. THE DEVICE WAS REPROGRAMMED AND INTERVENTION IS LIKELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PACEMAKER OVERSENSED NOISE RESULTING IN PACING INHIBITION WITH ASYSTOLE FOR MORE THAN TWO SECONDS. THE PATIENT IS PACEMAKER DEPENDENT PATIENT AND WAS SYNCOPAL. THE PATIENT WAS PRESCRIBED A HOLTER MONITOR WHICH CONFIRMED FREQUENT INSTANCES OF NOISE WITH PACING INHIBITION. ISOMETRICS AND POCKET MANIPULATION WERE SUCCESSFULLY IN RECREATING NOISE. THE DEVICE WAS REPROGRAMMED AND INTERVENTION IS LIKELY. THE DEVICE WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PACEMAKER OVERSENSED NOISE RESULTING IN PACING INHIBITION WITH ASYSTOLE FOR MORE THAN TWO SECONDS. THE PATIENT IS PACEMAKER DEPENDENT PATIENT AND WAS SYNCOPAL. THE PATIENT WAS PRESCRIBED A HOLTER MONITOR WHICH CONFIRMED FREQUENT INSTANCES OF NOISE WITH PACING INHIBITION. ISOMETRICS AND POCKET MANIPULATION WERE SUCCESSFULLY IN RECREATING NOISE. THE DEVICE WAS REPROGRAMMED AND INTERVENTION IS LIKELY. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844493 INGENIO PULSE-GENERATOR, SINGLE CHAMBER, SINGLE LWW BOSTON SCIENTIFIC CORPORATION J172 104137 00802526496059

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R