MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? X4 CRT-D; cardiac resynchronization therapy defibrillator (CRT-D)

Model Number	G156
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Data Problem (3196)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system was interrogated with a programmer that had an inaccurate date and time group.Ts discussed the programmer would need to be evaluated to resolve this.It was also noted this crt-d system exhibited high out of range pacing impedance measurements on the right atrial (ra) lead.Technical services (ts) noted the atrial tachy response (atr) episode showed non-physiologic noise and discussed it was probable early signs of a lead fracture.It was also noted the patient reported not feeling well recently.The patient was scheduled for an in-clinic interrogation to synch the programmer with the accurate date and time.No additional adverse patient effects were reported.This crt-d remains in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: DYNAGEN? X4 CRT-D
• Common Device Name: cardiac resynchronization therapy defibrillator (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 E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50715895
• Report Number: 2124215-2026-48440
• Device Sequence Number: 21295076
• Product Code: NIK
• UDI-Device Identifier: 00802526534669
• UDI-Public: (01)00802526534669(17)191221
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/21/2019
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 379067
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 02/16/2018
• 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
• Patient Age: 35 YR
• Patient Sex: Female