MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number	G154
Medical Device Problem Codes	Over-Sensing (1438); Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	05/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains in service; 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.
Event or Problem Description
It was reported that the health care professional (hcp) requested a review of an arrythmia episode for this cardiac resynchronization therapy defibrillator (crt-d).Technical services (ts) reviewed device data and observed atrial channel oversensing of ventricular signals with biventricular (biv) pacing.After, an early right ventricular (rv) beat was recorded.Ts suspected that this induced junctional tachycardia.The rhythm broke after approximately five to six seconds.Ts recommended the hcp refer to electrophysiology (ep).This crt-d remains in service.No adverse patient effects were reported.

• Brand Name: DYNAGEN? 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 ; 6515826168
• MDR Report Key: 25523829
• Report Number: 2124215-2026-32109
• Device Sequence Number: 5649772
• Product Code: NIK
• UDI-Device Identifier: 00802526534652
• UDI-Public: (01)00802526534652(17)190919
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 06/16/2026

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: 09/19/2019
• Device Model Number: G154
• Device Catalogue Number: G154
• Device Lot Number: 102555
• 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: 05/21/2026
• Initial Report FDA Received Date: 06/16/2026
• Date Device Manufactured: 10/19/2017
• 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: Other
• Patient Sex: Female