BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY?+

    MDR report key: 20630627 · Received November 7, 2024

    Report

    Report Number
    2124215-2024-70119
    Event Type
    Injury
    Date Received
    November 7, 2024
    Date of Event
    October 3, 2024
    Report Date
    April 23, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526604577
    PMA / PMN Number
    P150012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS AMENDED TO UPDATE INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) CODES. INCOMPLETE CODING OF THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH CAPA-8580, WHICH FOCUSED ON IDENTIFYING AND REMEDIATING INCOMPLETE CODING OF EVENTS. ADDED PATIENT CODE E060104. THE LEAD REMAINS IMPLANTED AND 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 A LOW AMPLITUDE, DECREASING FROM 15MV TO 1.9MV WITH STABLE PACING IMPEDANCE MEASUREMENTS. NO NOISE OBSERVED, HOWEVER, A CHEST X-RAY SHOWED THAT THIS RV LEAD HAD PULLED BACK. THE RV LEAD WAS REPROGRAMMED TO MAXIMUM OUTPUTS. THE PATIENT REPORTED NO SYMPTOMS, BUT THEIR HEART RATE APPEARED TO BE IN THE 40 BPM RANGE ON THEIR REMOTE MONITORING SYSTEM. IN ADDITION, THIS PATIENT UNDERWENT A RV LEAD REVISION AND THE LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOW AMPLITUDE FROM 15 MILLI VOLTS TO 1.9 MILLI VOLTS WITH IMPEDANCE STABLE. NO NOISE OBSERVED, HOWEVER, A CHEST X RAY SHOWED THAT THIS RV LEAD PULLED BACK. THIS RV LEAD WAS REPROGRAMMED FROM RV SENSING TO 1.0 MILLI VOLTS AND MAX RV OUTPUT. IN ADDITION, THIS PATIENT UNDERWENT RV LEAD REVISION AND REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465874 INGEVITY?+ DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES NVN BOSTON SCIENTIFIC CORPORATION 7841 1501304 00802526604577

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Hospitalization| R