BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 21379696 · Received February 13, 2025

    Report

    Report Number
    2124215-2025-08269
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    July 28, 2023
    Report Date
    March 24, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    UDI-DI
    00802526531262
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS, WITH RECENT MEASUREMENTS IN THE 132-133 OHMS RANGE. IT WAS NOTED THAT THIS LEAD HAD A DELIVERED SHOCK IMPEDANCE OF 88 OHMS FROM 2021. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS OR INTERVENTIONS WERE REPORTED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS, WITH RECENT MEASUREMENTS IN THE 132-133 OHMS RANGE. IT WAS NOTED THAT THIS LEAD HAD A DELIVERED SHOCK IMPEDANCE OF 88 OHMS FROM 2021. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS OR INTERVENTIONS WERE REPORTED AT THIS TIME. ADDITIONAL INFORMATION RECEIVED REPORTED THAT RV LEAD CONTINUED TO EXHIBIT HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS, WITH A MEASUREMENT AS HIGH AS 148 OHMS IN NOVEMBER 2025. TECHNICAL SERVICES (TS) DISCUSSED PROGRAMMING CONSIDERATIONS AND NEXT STEPS, INCLUDING POSSIBLE LEAD REVISION. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS OR INTERVENTIONS WERE REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490671 ENDOTAK RELIANCE G PERMANENT DEFIBRILLATOR ELECTRODES NVY BOSTON SCIENTIFIC CORPORATION 0295 419703 00802526531262

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female