MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM¿ CRT-D; cardiac resynchronization therapy defibrillator

Model Number	G124
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate anti-tachycardia pacing (atp) and an inappropriate shock due to atrial fibrillation (af).The rate was accelerated into the ventricular fibrillation (vf) zone after atp was delivered, but a shock terminated the arrhythmia.Technical services (ts) discussed potential programming options for this device.This crt-d remains in service.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM¿ CRT-D
• Common Device Name: cardiac resynchronization therapy defibrillator
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel, E91T8 62; EI E91T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50569232
• Report Number: 2124215-2026-46743
• Device Sequence Number: 18768610
• Product Code: NIK
• UDI-Device Identifier: 00802526589102
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 09/22/2024
• Device Model Number: G124
• Device Catalogue Number: G124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male