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

Model Number	G126
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) called technical services (ts) and reported a syncopal episode.A patient initiated interrogation (pii) was performed, however the transmission initially failed.Ts walked the patient through troubleshooting efforts.Troubleshooting efforts were successful.Ts referred the patient to the device treating clinic for further evaluation.At this time, no adverse patient effects were reported.This crt-d remains in service.

• Brand Name: MOMENTUM? CRT-D
• Common Device Name: cardiac resynchronization 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: 25437442
• Report Number: 2124215-2026-30578
• Device Sequence Number: 16042083
• Product Code: NIK
• UDI-Device Identifier: 00802526589140
• UDI-Public: (01)00802526589140(17)250607
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2026

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: 06/07/2025
• Device Model Number: G126
• Device Catalogue Number: G126
• Device Lot Number: 107498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 08/10/2026
• Date Device Manufactured: 02/23/2024
• 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
• Patient Age: 70 YR
• Patient Sex: Male