BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 23777289 · Received December 11, 2025

    Report

    Report Number
    2124215-2025-90325
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526422072
    PMA / PMN Number
    P910073/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE UDI REGULATION AND AS A RESULT, THE COMPLETE UDI IS NOT AVAILABLE. APPLICABLE US PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OF 128 OHMS. TECHNICAL SERVICES (TS) STATED THERE WAS NO NEW DATA IN LXT AND THAT THE PREVIOUS TRANSMISSIONS WERE STABLE MEASUREMENTS. TS RECOMMENDS INCREASING THE UPPER SHOCK IMPEDANCE LIMIT TO 150 OHMS, AND THAT IF ANOTHER ALERT OCCURS THEN TO CONSIDER LEAD REVISION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2776669 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 0185 00802526422072

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female