MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM? X4 CRT-D; cardiac resynchronization therapy defibrillator (CRT-D)

Model Number	G138
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Convert Rhythm (1540); Low impedance (2285); Device Sensing Problem (2917)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	08/16/2026
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 this cardiac resynchronization therapy defibrillator (crt-d) delivered six shocks for ventricular tachycardia (vt).The first five shocks did not convert the arrhythmia; however, the sixth shock was successful.The patient mentioned they became unconscious.Approximately two days later, the crt-d exhausted all programmed therapy and was unable to convert the rhythm and the patient was externally rescued.Technical services (ts) reviewed the data and noted shock impedance measurements were low but within normal range.Both the right atrial (ra) and right ventricular (rv) leads were non-boston scientific leads.Ts also observed intermittent decreases in ra pacing impedance resulting in low, out-of-range measurements.Approximately eight months earlier, following a procedure, this crt-d recorded a signal artifact monitor (sam) episode with noise present on all channels.Subsequent to that procedure, decreases in both rv and left ventricular (lv) lead impedances were noted.Ts additionally observed fine rv lead noise that was not sensed by the device.The integrity of the rv lead was questioned, however ts explained they could not determine the full integrity of the lead.This crt-d remains in service.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM? X4 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: 50610807
• Report Number: 2124215-2026-47262
• Device Sequence Number: 10634412
• Product Code: NIK
• UDI-Device Identifier: 00802526589188
• UDI-Public: (01)00802526589188(17)241213
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2026

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: 12/13/2024
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 392476
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 01/04/2023
• 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: Other; Life Threatening
• Patient Age: 68 YR
• Patient Sex: Male