BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 20727277 · Received November 19, 2024

    Report

    Report Number
    2124215-2024-72805
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    April 2, 2024
    Report Date
    February 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526536786
    PMA / PMN Number
    N970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS OF THE RETURNED DEVICE FOUND NO EVIDENCE OF DEVICE DEFECT, MALFUNCTION, OR DAMAGE OUTSIDE THE BOUNDS OF NORMAL MEDICAL USE. THE DEVICE WAS SUBJECTED TO AND PASSED ALL AUTOMATED TESTING. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS EXHIBITING AN GRADUAL RISE IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED AND DETERMINED THAT WAS PHYSIOLOGIC. IN ADDITION, IT WAS NOTED THAT THERE WERE RECORDED TWO SIGNAL ARTIFACT MONITORING (SAM) EPISODES DUE TO ATRIAL FIBRILLATION. THIS RESULTED IN THE MINUTE VENTILATION (MV) FEATURE BEING AUTOMATICALLY DISABLED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PACEMAKER TRIGGERED TO LEAD SAFETY SWITCH. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE PACEMAKER WAS EXPLANTED, WHILE THE RV LEAD WAS SURGICALLY ABANDONED. BOTH PRODUCTS WERE SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS EXHIBITING AN GRADUAL RISE IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED AND DETERMINED THAT WAS PHYSIOLOGIC. IN ADDITION, IT WAS NOTED THAT THERE WERE RECORDED TWO SIGNAL ARTIFACT MONITORING (SAM) EPISODES DUE TO ATRIAL FIBRILLATION. THIS RESULTED IN THE MINUTE VENTILATION (MV) FEATURE BEING AUTOMATICALLY DISABLED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PACEMAKER TRIGGERED TO LEAD SAFETY SWITCH. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE PACEMAKER WAS EXPLANTED, WHILE THE RV LEAD WAS SURGICALLY ABANDONED. BOTH PRODUCTS WERE SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106049 INGENIO PACEMAKER LWP BOSTON SCIENTIFIC CORPORATION K174 113812 00802526536786

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Hospitalization| R