BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE DEVICE

    MDR report key: 24619285 · Received March 17, 2026

    Report

    Report Number
    2124215-2026-14660
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    April 1, 2025
    Report Date
    March 17, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WANG, NORMAN C., ET AL. (2025). PULSED FIELD ABLATION IN PERSISTENT LEFT SUPERIOR VENA CAVA FOR ATRIAL FIBRILLATION VIA INTERRUPTED INFERIOR VENA CAVA WITH AZYGOS CONTINUATION UTILIZING NOVEL ELECTROANATOMIC MAPPING FEATURES IN THE PRESENCE OF A PERMANENT PACEMAKER. HEART RHYTHM CASE REPORTS, VOL 11, NO 9, SEPTEMBER 2025. HTTPS://DOI.ORG/10.1016/J.HRCR.2025.06.026. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL EVENT INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION TO B5: UPDATED FOR CLARITY. CORRECTION TO H6: ADDED DEVICE CODE "A0712/PACING PROBLEM," PATIENT CODE "E060101/ASYSTOLE," AND IMPACT CODE "F1001/ABSENCE OF TREATMENT." REMOVED IMPACT CODE "F26/NO HEALTH CONSEQUENCES OR IMPACT" AND PATIENT CODE "E2403/NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS."

    Additional Manufacturer Narrative · 0

    WANG, NORMAN C., ET AL. (2025). PULSED FIELD ABLATION IN PERSISTENT LEFT SUPERIOR VENA CAVA FOR ATRIAL FIBRILLATION VIA INTERRUPTED INFERIOR VENA CAVA WITH AZYGOS CONTINUATION UTILIZING NOVEL ELECTROANATOMIC MAPPING FEATURES IN THE PRESENCE OF A PERMANENT PACEMAKER. HEART RHYTHM CASE REPORTS, VOL 11, NO 9, SEPTEMBER 2025. HTTPS://DOI.ORG/10.1016/J.HRCR.2025.06.026. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL EVENT INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PER ARTICLE OF INTEREST LITERATURE REVIEW THAT PACEMAKER NOISE WITH OVERSENSING, PACEMAKER SUPPRESSION, AND 3.6 SECONDS OF ASYSTOLE WERE OBSERVED DURING A PULSED FIELD ABLATION (PFA) PROCEDURE. LEAD PARAMETERS WERE COMPARABLE BEFORE AND AFTER PFA APPLICATIONS. A 6-WEEK FOLLOW-UP PACEMAKER CHECK DEMONSTRATED NO RECORDED ATRIAL TACHYARRHYTHMIAS AFTER THE ABLATION PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED, AND DEVICE IMPLANT STATUS WAS UNAVAILABLE. DUE TO THE LIMITED INFORMATION RECEIVED, FURTHER FOLLOW-UP TO OBTAIN RELATED DETAILS WAS NOT POSSIBLE.

    Description of Event or Problem · 0

    IT WAS REPORTED PER ARTICLE OF INTEREST LITERATURE REVIEW THAT PACEMAKER NOISE WITH OVERSENSING WAS OBSERVED DURING A PULSED FIELD ABLATION (PFA) PROCEDURE. LEAD PARAMETERS WERE COMPARABLE BEFORE AND AFTER PFA APPLICATIONS. A 6-WEEK FOLLOW-UP PACEMAKER CHECK DEMONSTRATED NO RECORDED ATRIAL TACHYARRHYTHMIAS AFTER THE ABLATION PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND DEVICE IMPLANT STATUS WAS UNAVAILABLE. DUE TO THE LIMITED INFORMATION RECEIVED, FURTHER FOLLOW-UP TO OBTAIN RELATED DETAILS WAS NOT POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682540 IMPLANTABLE DEVICE LWP BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown