BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE 4-FRONT?

    MDR report key: 23827384 · Received December 17, 2025

    Report

    Report Number
    2124215-2025-91355
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    October 11, 2025
    Report Date
    December 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    UDI-DI
    00802526592867
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SYSTEM, WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD, EXHIBITED OVERSENSING, WHICH RESULTED IN INAPPROPRIATE SINGLE SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) FOR MULTIPLE EPISODES. TECHNICAL SERVICES (TS) WAS CONSULTED AND INDICATED THAT THE OVER SENSING IS MOST LIKELY DUE TO P WAVE DETECTION AND COULD ALSO BE POSITIONAL, AS THE MOST RECENT THERAPY OCCURRED WHILE THE PATIENT WAS IN BED. A FAST INTRINSIC RATE COMBINED WITH OVER SENSING LED TO VENTRICULAR FIBRILLATION DETECTION. TS PROVIDED PROGRAMMING RECOMMENDATIONS AND ADVISED OBTAINING IMAGING TO REVIEW LEAD POSITIONING. THE FIELD REPRESENTATIVE INDICATED THE DEVICE WAS REPROGRAMMED AND PHYSICIAN MADE MEDICATION CHANGES. THIS SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197846 RELIANCE 4-FRONT? IMPLANTABLE LEAD NVY BOSTON SCIENTIFIC CORPORATION 0673 118149 00802526592867

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other