BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE MRI SR

    MDR report key: 17597041 · Received August 22, 2023

    Report

    Report Number
    2124215-2023-45196
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    August 16, 2023
    Report Date
    December 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559204
    PMA / PMN Number
    P150012/S000
    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. DEVICE TELEMETRY DATA CONFIRMED IT WAS OPERATING IN SAFETY MODE AND THAT BRADYCARDIA THERAPY REMAINED AVAILABLE. ENGINEERS DETERMINED THAT THIS DEVICE WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH INTERNAL CELL IMPEDANCE WITHIN THE BATTERY. THE HIGH INTERNAL IMPEDANCE PUT THIS DEVICE AT RISK OF EXPERIENCING TRANSIENT VOLTAGE DECREASES (AND ASSOCIATED RESETS) DURING PERIODS OF HIGH-POWER CONSUMPTION. WHEN BATTERY VOLTAGE DROPS BELOW A MINIMUM THRESHOLD, A SYSTEM RESET IS PERFORMED. IF THREE SYSTEM RESETS OCCUR WITHIN A 48-HOUR PERIOD, THE DEVICE IS DESIGNED TO IMMEDIATELY ENTER SAFETY MODE OPERATION TO MAINTAIN BACK-UP PACING WITH PRE-DEFINED, NON-PROGRAMMABLE SETTINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED DUE TO THE DEVICE GOING INTO SAFETY MODE. THE DEVICE WAS UPGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED DUE TO THE DEVICE GOING INTO SAFETY MODE. THE DEVICE WAS UPGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50565 ACCOLADE MRI SR IMPLANTABLE PACEMAKER LWP BOSTON SCIENTIFIC CORPORATION L310 746681 00802526559204

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| H