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); Under-Sensing (1661)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) presented to the emergency room (er) with loss of brain function.Device data showed approximately 26 seconds of ventricular fibrillation (vf); however, undersensing was noted, so the total duration of the vf episode is unknown.A pause greater than two seconds was also observed, and the patient was hospitalized.No additional adverse patient effects were reported.This crt-d remains in service.

• 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: 22898991
• Report Number: 2124215-2025-60004
• Device Sequence Number: 15666477
• Product Code: NIK
• UDI-Device Identifier: 00802526589140
• UDI-Public: (01)00802526589140(17)241205
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/05/2024
• Device Model Number: G126
• Device Catalogue Number: G126
• Device Lot Number: 107063
• 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: 08/08/2025
• Initial Report FDA Received Date: 08/26/2025
• Date Device Manufactured: 01/25/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female