BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE MRI DR

    MDR report key: 22170623 · Received June 9, 2025

    Report

    Report Number
    2124215-2025-37721
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    May 21, 2025
    Report Date
    September 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION. CODE ADDED: A070101. H6 FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING THE FIELD REPRESENTATIVE CONSULTATION, THE PHYSICIAN HAD INFORMED THAT THIS PATIENT EXPERIENCED A SYNCOPE EPISODE A FEW WEEKS PRIOR. UPON REVIEW, THE RIGHT VENTRICULAR (RV) LEAD ON THIS PACEMAKER HAD BEEN REPROGRAMMED. THE PHYSICIAN ALSO MENTIONED THAT DURING THE LAST DEVICE INTERROGATION, THE PACING THRESHOLDS WERE HIGHLY UNSTABLE. SINCE THE URGENT REPROGRAMMING, THE CONDITION HAD BEEN STABILIZED, BUT THE THRESHOLDS WERE STILL HIGH. SUBSEQUENTLY, A NEW THRESHOLD TESTING WAS CONDUCTED AND REPROGRAMMED. THIS PACEMAKER REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING THE FIELD REPRESENTATIVE CONSULTATION, THE PHYSICIAN HAD INFORMED THAT THIS PATIENT EXPERIENCED A SYNCOPE EPISODE A FEW WEEKS PRIOR. UPON REVIEW, THE RIGHT VENTRICULAR (RV) LEAD ON THIS PACEMAKER HAD BEEN REPROGRAMMED. THE PHYSICIAN ALSO MENTIONED THAT DURING THE LAST DEVICE INTERROGATION, THE PACING THRESHOLDS WERE HIGHLY UNSTABLE. SINCE THE URGENT REPROGRAMMING, THE CONDITION HAD BEEN STABILIZED, BUT THE THRESHOLDS WERE STILL HIGH. SUBSEQUENTLY, A NEW THRESHOLD TESTING WAS CONDUCTED AND REPROGRAMMED. THIS PACEMAKER REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333111 ACCOLADE MRI DR PACEMAKER LWP BOSTON SCIENTIFIC CORPORATION L311 805094 00802526559235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention