MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM? X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS

Model Number	G138
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
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 right ventricular (rv) lead and cardiac resynchronization therapy defibrillators (crt-d) exhibited an increase in shocking impedances reaching high, out of range measurements.The system has a triad configuration.Technical services (ts) recommend a breakdown of shock vectors, to program rv to pg would proximal coil would be out of range.Also, a defibrillation threshold (dft) dft test was recommended, however, if rv coil was out of range, the recommendation was to replace lead.Furthermore, isometrics with serial and wireless ecg to provide visibility to proximately of proximal coil were recommended.The rv lead and the crt-d still remain in service.No adverse patient effects were reported.

• Brand Name: MOMENTUM? X4 CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS
• 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: 25661283
• Report Number: 2124215-2026-34651
• Device Sequence Number: 10407203
• Product Code: NIK
• UDI-Device Identifier: 00802526589188
• UDI-Public: (01)00802526589188(17)231125
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/25/2023
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 389436
• 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: 06/11/2026
• Initial Report FDA Received Date: 06/29/2026
• Date Device Manufactured: 12/02/2021
• 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
• Patient Age: 63 YR
• Patient Sex: Female