MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM? CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number	G126
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); High Capture Threshold (3266)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	05/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered one inappropriate shock and anti-tachycardia pacing (atp) due to atrial flutter with rapid ventricular response (rvr).Technical services (ts) reviewed and noted no noise or impedance measurements out of range were noted.Ts was also provided alternatives with programing this device into left ventricular (lv) lead pacing only.This device remains in service.No adverse patient effects were reported.Additional information was received from the field.The right ventricular (rv) lead of this crt-d system exhibited loss of capture (loc) due to fracture.Subsequently, reprograming was performed to obtain left ventricular (lv) lead pacing only.No adverse patient effects were reported.
Additional Manufacturer Narrative
Updated b5 describe event or problem with additional information received from the field.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered one inappropriate shock and anti-tachycardia pacing (atp) due to atrial flutter with rapid ventricular response (rvr).Technical services (ts) reviewed and noted no noise or impedance measurements out of range were noted.Ts was also provided alternatives with programing this device into left ventricular (lv) lead pacing only.This device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: MOMENTUM? CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24064119
• Report Number: 2124215-2026-02339
• Device Sequence Number: 9388014
• Product Code: NIK
• UDI-Device Identifier: 00802526589140
• UDI-Public: (01)00802526589140(17)240419
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/19/2024
• Device Model Number: G126
• Device Catalogue Number: G126
• Device Lot Number: 106594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/02/2026
• Date Device Manufactured: 05/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male