MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? X4 CRT-D; Cardiac Resynchronization Therapy Defibrillator

Model Number	G156
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Inaccurate Synchronization (1609)
Health Effect - Clinical Codes	Arrhythmia (1721); Tachycardia (2095); Shock from Patient Lead(s) (3162)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after this cardiac resynchronization therapy defibrillator (crt-d) provided appropriate anti-tachycardia pacing (atp), the rhythm accelerated into fast ventricular tachycardia (vt).There was also a slightly delayed therapy response due to the arrhythmia starting in the vt monitor only zone.The atp and shocks had successfully converted the patient's arrhythmias, and the patient was seen in the emergency room.Technical services (ts) discussed optimization settings.This crt-d remains in service and no additional adverse patient effects were reported.

• Brand Name: DYNAGEN? X4 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 E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 22919065
• Report Number: 2124215-2025-60777
• Device Sequence Number: 18580782
• Product Code: NIK
• UDI-Device Identifier: 00802526534669
• UDI-Public: (01)00802526534669(17)200514
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2026

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: 05/14/2020
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 380021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 05/31/2018
• 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: 61 YR
• Patient Sex: Male