BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE 4-FRONT

    MDR report key: 24881448 · Received April 15, 2026

    Report

    Report Number
    2124215-2026-20277
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 15, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    UDI-DI
    00802526592867
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IN SERVICE; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE OF 140 OHMS INITIALLY; HOWEVER, SUBSEQUENTLY DECREASED TO 110-116 OHMS RANGE. ALL OTHER MEASUREMENTS WERE NOTED TO BE NORMAL. TECHNICAL SERVICES (TS) SUGGESTED TO CONTINUE MONITORING. THIS LEAD REMAIN IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952171 RELIANCE 4-FRONT IMPLANTABLE LEAD NVY BOSTON SCIENTIFIC CORPORATION 0673 300648 00802526592867

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male