BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 23598088 · Received November 19, 2025

    Report

    Report Number
    2124215-2025-84744
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526604546
    PMA / PMN Number
    P150012/S083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO FIELD D4: SERIAL NUMBER. CORRECTION TO FIELD D4: UNIQUE IDENTIFIER (UDI).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN PACING IMPEDANCE AND HIGH CAPTURE THRESHOLDS. THE PACING IMPEDANCE REMAINED WITHIN RANGE. THE CALLER WANTED TECHNICAL SERVICES (TS) INSIGHT ON AN IMPLANT PROCEDURE. IT WAS NOTED THAT THE PATIENT WAS DUE FOR A THERAPY UPGRADE. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN PACING IMPEDANCE AND HIGH CAPTURE THRESHOLDS. THE PACING IMPEDANCE REMAINED WITHIN RANGE. THE CALLER WANTED TECHNICAL SERVICES (TS) INSIGHT ON AN IMPLANT PROCEDURE. IT WAS NOTED THAT THE PATIENT WAS DUE FOR A THERAPY UPGRADE. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490893 INGEVITY+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7842 1515200 00802526604546

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R