BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOMENTUM CRT-D

    MDR report key: 22812107 · Received August 14, 2025

    Report

    Report Number
    2124215-2025-56984
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    January 1, 2024
    Report Date
    September 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    PMA / PMN Number
    P010012/S436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO UPDATE B5 (DESCRIBE EVENT OR PROBLEM), AND H11 ADDITIONAL MFR NARRATIVE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE EXHIBITED NON-PHYSIOLOGICAL NOISE, LOW RIGHT ATRIAL (RA) PACING IMPEDANCE, RIGHT VENTRICULAR (RV) HIGH OUT OF RANGE SHOCK IMPEDANCE GRADUALLY INCREASING, AND LEFT VENTRICULAR (LV) FAILURE TO CAPTURE. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. A TECHNICAL SERVICE (TS) CONSULTANT REVIEWED DEVICE DATA, ADVISING THAT THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD EXHIBITED LOW PACING IMPEDANCE (LESS THAN 200 OHMS). THE BOSTON SCIENTIFIC, RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, SHOCK IMPEDANCE OUT OF RANGE, GRADUALLY INCREASING SINCE (B)(6) 2024 (90 OHMS TO 140 OHMS) AND THE NON-BOSTON SCIENTIFIC LEFT VENTRICULAR (LV) LEAD EXHIBITED FAILURE TO CAPTURE. THE CONSULTANT RECOMMENDED ADDITIONAL TROUBLESHOOTING AND PROGRAMMING OPTIONS. ALL PRODUCT REMAIN IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE AND NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD, EXHIBITED NON-PHYSIOLOGICAL NOISE, AND PACING IMPEDANCE >200 OHMS. THE RIGHT VENTRICULAR (RV) HIGH OUT OF RANGE SHOCK IMPEDANCE GRADUALLY INCREASING, AND LEFT VENTRICULAR (LV) FAILURE TO CAPTURE. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. A TECHNICAL SERVICE (TS) CONSULTANT REVIEWED DEVICE DATA, ADVISING THAT THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD EXHIBITED LOW PACING IMPEDANCE (LESS THAN 200 OHMS). THE BOSTON SCIENTIFIC, RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, SHOCK IMPEDANCE OUT OF RANGE, GRADUALLY INCREASING SINCE (B)(6) 2024 (90 OHMS TO 140 OHMS) AND THE NON-BOSTON SCIENTIFIC LEFT VENTRICULAR (LV) LEAD EXHIBITED FAILURE TO CAPTURE. THE CONSULTANT RECOMMENDED ADDITIONAL TROUBLESHOOTING AND PROGRAMMING OPTIONS. ALL PRODUCTS REMAIN IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NEW INFORMATION WAS RECEIVED INDICATING THAT HIS CRT-D DEVICE EXHIBITED (3) EPISODES OF ANTI-TACHYCARDIA PACING (ATP) AND (1) 41J SHOCK. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. RHYTHMCARE REVIEWED DEVICE DATA, NOTING ARRHYTHMIA STARTED SUDDENLY AND DURING THE ATP EPISODES, ATRIAL FREQUENCY > A FIB (180 BPM). THE ATP WAS NOT ABLE TO CORRECT THE ARRHYTHMIA, RESULTING IN 1 41J SHOCK WITH NORMAL RHYTHM RETURNING. RHYTHMCARE PROVIDED RECOMMENDATIONS FOR MONITORING THE PATIENT CLOSELY. ALL PRODUCTS REMAIN IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866182 MOMENTUM CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION G125 138987

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown