BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE? MRI EL DR

    MDR report key: 20009302 · Received August 21, 2024

    Report

    Report Number
    2124215-2024-51572
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    August 6, 2024
    Report Date
    April 23, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559266
    PMA / PMN Number
    P150012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    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 PATIENT CODE E060104. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; 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.

    Additional Manufacturer Narrative · 0

    CORRECTIVE FIELDS: D4. CATALOG NUMBER, D4. SERIAL NUMBER

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED HIGH CAPTURE THRESHOLDS AND LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED CAPTURE WAS OBTAINED IN UNIPOLAR. THE PATIENT PRESENTED INTRINSIC BRADYCARDIA DURING AN ATTEMPTED MAGNETIC RESONANCE IMAGING (MRI) SCAN, WHICH WAS THEN CANCELLED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS OBTAINED, TECHNICAL SERVICES (TS) STATED IF LEAD PRESENTS AN ISSUE, PERFORMING A MRI SCAN WOULD BE CONTRAINDICATED. FURTHER INFORMATION WAS RECEIVED, INDICATING THE PACEMAKER WAS EXPLANTED AND REPLACED DUE TO THERAPY UPGRADE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER LEAD EXHIBITED HIGH CAPTURE THRESHOLDS AND LOSS OF CAPTURE. THE PATIENT PRESENTED INTRINSIC BRADYCARDIA DURING AN ATTEMPTED MRI WHICH WAS CANCELLED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED HIGH CAPTURE THRESHOLDS AND LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT PRESENTED INTRINSIC BRADYCARDIA DURING AN ATTEMPTED MRI WHICH WAS CANCELLED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS OBTAINED, TECHNICAL SERVICES (TS) STATED IF LEAD PRESENTS AN ISSUE, PERFORMING A MAGNETIC RESONANCE IMAGING (MRI) WOULD BE CONTRAINDICATED. FURTHER INFORMATION WAS RECEIVED. THE PACEMAKER WAS EXPLANTED AND REPLACED DUE TO THERAPY UPGRADE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED HIGH CAPTURE THRESHOLDS AND LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT PRESENTED INTRINSIC BRADYCARDIA DURING AN ATTEMPTED MRI WHICH WAS CANCELLED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515419 ACCOLADE? MRI EL DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L331 908624 00802526559266

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male