BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 16292722 · Received February 3, 2023

    Report

    Report Number
    2124215-2023-04441
    Event Type
    Injury
    Date Received
    February 3, 2023
    Date of Event
    November 7, 2006
    Report Date
    February 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTB
    UDI-DI
    00802526397738
    PMA / PMN Number
    P960006/S005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL LEAD WAS SURGICALLY ABANDONED DUE TO EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCES MEASUREMENTS AND PACING INHIBITION. ANOTHER LEAD WAS IMPLANTED INSTEAD. FURTHERMORE, IT WAS CLARIFIED THAT THE LEAD HAS BEEN NON-FUNCTIONAL SINCE AFTER IMPLANT. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL LEAD WAS SURGICALLY ABANDONED DUE TO EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCES MEASUREMENTS AND PACING INHIBITION. ANOTHER LEAD WAS IMPLANTED INSTEAD. FURTHERMORE, IT WAS CLARIFIED THAT THE LEAD HAS BEEN NON-FUNCTIONAL SINCE AFTER IMPLANT. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480728 FLEXTEND IMPLANTABLE LEAD DTB BOSTON SCIENTIFIC CORPORATION 4087 00802526397738

    Patients

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