MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM? X4 CRT-D; Cardiac resyncronization therapy defibrillator

Model Number	G138
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced a ventricular tachycardia episode.The device delivered anti-tachycardia pacing (atp) however, this accelerated the rhythm into ventricular fibrillation (vf).The device detected the vf and delivered a shock, ending the episode.It was decided to explant and replace the device.No further adverse patient effects were reported.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced a ventricular tachycardia episode.The device delivered anti-tachycardia pacing (atp) however, this accelerated the rhythm into ventricular fibrillation (vf).The device detected the vf and delivered a shock, ending the episode.It was decided to explant and replace the device.No further adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.Additional information was added to the following fields: h6: impact codes.

• Brand Name: MOMENTUM? X4 CRT-D
• Common Device Name: Cardiac resyncronization therapy defibrillator
• 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 ; +1(651)582-6168
• MDR Report Key: 25786360
• Report Number: 2124215-2026-37123
• Device Sequence Number: 10686678
• Product Code: NIK
• UDI-Device Identifier: 00802526589188
• UDI-Public: (01)00802526589188(17)230429
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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: 04/29/2023
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 387964
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• 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: 07/22/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 05/25/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male