BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE 4-FRONT

    MDR report key: 16244397 · Received January 25, 2023

    Report

    Report Number
    2124215-2023-03036
    Event Type
    Injury
    Date Received
    January 25, 2023
    Date of Event
    January 5, 2023
    Report Date
    January 25, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526592867
    PMA / PMN Number
    P910073/S145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED DUE TO EXHIBITING HIGH PACING THRESHOLDS, LOSS OF CAPTURE, LOW WITHIN RANGE PACING IMPEDANCE MEASUREMENTS AND PACING INHIBITION. THE LEAD EXPERIENCED DIFFICULTY TO BE EXTRACTED DURING THE PROCEDURE WHICH LED TO THE DECISION TO BE SURGICALLY ABANDONED. ANOTHER LEAD WAS IMPLANTED INSTEAD. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203213 RELIANCE 4-FRONT IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 0673 162637 00802526592867

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Hospitalization| R