BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY? STEERABLE

    MDR report key: 21344559 · Received February 10, 2025

    Report

    Report Number
    2124215-2025-07016
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 25, 2025
    Report Date
    April 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    UDI-DI
    00802526419324
    PMA / PMN Number
    P050046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 DEVICE CODE A070101. 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 THE HEALTH CARE PROFESSIONAL (HCP) CALLED FOR REVIEW OF A PRESENTING ELECTROGRAM (EGM). TECHNICAL SERVICES (TS) REVIEWED THE DATA AND FOUND THERE IS INTERMITTENT LEFT VENTRICULAR (LV) LOSS OF CAPTURE. ADDITIONALLY, THE LV IMPEDANCES HAVE INCREASED FROM 400 OHMS RANGE TO OVER 1,456 OHMS OVER THE PAST YEAR. TS RECOMMENDED FURTHER TESTING OF THE LV LEAD. AT THIS TIME, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED FOR REVIEW OF A PRESENTING ELECTROGRAM (EGM). TECHNICAL SERVICES (TS) REVIEWED THE DATA AND FOUND THERE IS INTERMITTENT LEFT VENTRICULAR (LV) LOSS OF CAPTURE. ADDITIONALLY, THE LV IMPEDANCES HAVE INCREASED FROM 400 OHMS RANGE TO OVER 1,456 OHMS OVER THE PAST YEAR. TS RECOMMENDED FURTHER TESTING OF THE LV LEAD. AT THIS TIME, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394016 ACUITY? STEERABLE PERMANENT DEFIBRILLATOR ELECTRODES NVY BOSTON SCIENTIFIC CORPORATION 4554 180323 00802526419324

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male