MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; Defibrillator, Automatic Implantable Cardioverter, With Crt-D

Model Number	G125
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) system presented to the emergency room (er), and review of the presenting electrogram (egm) showed possible left-sided ventricular tachycardia (vt).A full device interrogation was planned for later that day.Additional information received reported that the patient was found to be in slow vt below the programmed detection rate, and the patient was was externally cardioverted to normal sinus rhythm successfully.This crt-d remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.The product was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• Brand Name: MOMENTUM CRT-D
• Common Device Name: Defibrillator, Automatic Implantable Cardioverter, With 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50047326
• Report Number: 2124215-2026-40183
• Device Sequence Number: 13421795
• Product Code: NIK
• UDI-Device Identifier: 00802526589126
• UDI-Public: (01)00802526589126(17)190817
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: 08/16/2019
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 123713
• 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: 07/22/2026
• Initial Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 08/28/2017
• 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
• Patient Sex: Male