BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 22564103 · Received July 22, 2025

    Report

    Report Number
    2124215-2025-49053
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    July 11, 2025
    Report Date
    July 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTB
    UDI-DI
    00802526397721
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVERSENSING, AS WELL AS LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS BELOW 200 OMHS, CAUSED BY DAMAGE TO THE INSULATION. THE PHYSICIAN OPTED TO EXPLANT AND REPLACE THIS LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817775 FLEXTEND IMPLANTABLE LEAD DTB BOSTON SCIENTIFIC CORPORATION 4086 00802526397721

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention| H