MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM¿ CRT-D; Implantable Cardiac Device

Model Number	G124
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered a shock, despite the patient only in ventricular tachycardia (vt).The device charged and diverted a shock as the rate went below the therapy threshold.The patient rhythm then reentered vt and the shock was delivered as the device cannot divert twice.Technical services (ts) confirmed the device operated per design.This device was subsequently explanted and returned.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM¿ CRT-D
• Common Device Name: Implantable Cardiac Device
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel, clonmel E91T8 62; EI E91T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50566425
• Report Number: 2124215-2026-45886
• Device Sequence Number: 18664979
• Product Code: NIK
• UDI-Device Identifier: 00802526589102
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 04/29/2022
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 498673
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 05/12/2020
• 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: 5 YR
• Patient Sex: Male