MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM? CRT-D; Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Model Number	G125
Medical Device Problem Codes	High impedance (1291); Failure to Convert Rhythm (1540); Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system experienced a ventricular fibrillation episode in which all programmed shocks were exhausted without successful conversion.A shock on ventricular tachycardia (vt) induced ventricular fibrillation (vf).The device recorded an alert due to shock impedance high out of range.During repeat defibrillation threshold testing, four episodes of induced ventricular fibrillation were not terminated, requiring external defibrillation.The patient was reported to be stable, and no surgical intervention plan had been determined at the time of the report.The device 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 E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25757525
• Report Number: 2124215-2026-36784
• Device Sequence Number: 9788211
• Product Code: NIK
• UDI-Device Identifier: 00802526589126
• UDI-Public: (01)00802526589126(17)221008
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2026

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: 10/08/2022
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 142640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 07/13/2026; 09/08/2026
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 08/05/2026; 09/09/2026
• Date Device Manufactured: 10/15/2020
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female