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

Model Number	G126
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Read Input Signal (1581); Under-Sensing (1661); Low impedance (2285); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Gfe sent for follow up about corrective actions.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this system, with a cardiac resynchronization therapy defibrillator (crt-d), right ventricular (rv) lead and right atrial (ra) lead, displayed an alert for the right ventricular automatic threshold (rvat) test in programmed amplitude or suspended mode.Technical services (ts) was consulted and discussed this was due to noise.During data review, ts also noted a gradual decrease in rv pacing impedance measurements.Additionally, atrial under sensing was observed due to the automatic gain control sensitivity settings.Ts recommended further evaluation in the clinic.This system remains in service.No adverse patient effects were reported.

• 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: 23890797
• Report Number: 2124215-2025-93044
• Device Sequence Number: 9359826
• Product Code: NIK
• UDI-Device Identifier: 00802526589140
• UDI-Public: (01)00802526589140(17)210917
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/24/2025

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: 09/17/2021
• Device Model Number: G126
• Device Catalogue Number: G126
• Device Lot Number: 104561
• 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: 12/15/2025
• Initial Report FDA Received Date: 12/24/2025
• Date Device Manufactured: 10/25/2019
• 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 Sex: Male