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

Model Number	G158
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	12/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced a syncopal event.Boston scientific technical services (ts) was consulted and upon review, it was noted that this device stored several pacemaker mediated tachycardia (pmt) episodes, however, these did not correlate to the timing of the syncopal event.Lead measurements were noted to be within range.Further information from the field representative confirmed the syncopal event was not device related, however, the cause of the event has not been determined.No additional adverse patient effects were reported.At this time, this device system remains in service.Additional information was received that this device was explanted due to unknown reasons.No additional adverse patient effects were reported.This device has been received for analysis.

• 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: 50063755
• Report Number: 2124215-2026-40507
• Device Sequence Number: 9212153
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: (01)00802526534904(17)191212
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: 12/12/2019
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 183875
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male