BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE MRI EL DR

    MDR report key: 21714736 · Received March 27, 2025

    Report

    Report Number
    2124215-2025-19230
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 14, 2025
    Report Date
    October 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526614736
    PMA / PMN Number
    P150012/S000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: D1 FIELD CORRECTION FROM INGEVITY+ TO ACCOLADE MRI EL DR D2A FIELD CORRECTION FROM IMPLANTABLE LEAD TO IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) D2B FIELD CORRECTION FROM NVN TO LWP D4 FIELD CORRECTION FROM 7841, (B)(6), 7841, 02/17/2024, (B)(6), 00802526559273, (B)(4), (B)(4) TO L331, 980604, L331, 02/24/2024, 980604, 00802526559273, (B)(4), (B)(4). (B)(6). E2 FIELD CORRECTION FROM YES TO NO. E3 FIELD CORRECTION FROM OTHER HEALTH CARE PROFESSIONAL TO NON-HEALTHCARE PROFESSIONAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ATRIAL INTRINSIC AMPLITUDE WAS OUT-OF-RANGE AND UNDERSENSING WAS OBSERVED ON THE ELECTROGRAM (EGM) FOR THIS PACEMAKER. THE PACEMAKER SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ATRIAL INTRINSIC AMPLITUDE WAS OUT-OF-RANGE AND UNDERSENSING WAS OBSERVED ON THE ELECTROGRAM (EGM) FOR THIS PACEMAKER. THE PACEMAKER SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED ADVISED THE STORED RIGHT VENTRICULAR AUTOMATIC THRESHOLD (RVAT) EGM SHOWED UNDERSENSING ON THE ATRIAL CHANNEL CAUSING INAPPROPRIATE VENTRICULAR PACING. CURRENTLY, THE ATRIAL SENSITIVITY IS PROGRAMMED AUTOMATIC GAIN CONTROL (AGC) AT 1.0MV (MILLIVOLTS). FURTHER REVIEW WAS RECOMMENDED. AT THIS TIME THE DEVICE REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470111 ACCOLADE MRI EL DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L331 980604 00802526614736

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown