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

Model Number	G158
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) to review the reports for this cardiac resynchronization therapy defibrillator (crt-d).Ts reviewed the data and discussed this crt-d delivered four anti-tachycardia pacing (atp) and four shocks for what appeared to be atrial fibrillation (af) with rapid ventricular response (rvr).Ts recommended following up with cardiology.No additional adverse patient effects were reported.This crt-d remains in service.
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) to review the reports for this cardiac resynchronization therapy defibrillator (crt-d).Ts reviewed the data and discussed this crt-d delivered four anti-tachycardia pacing (atp) and four shocks for what appeared to be atrial fibrillation (af) with rapid ventricular response (rvr).Ts recommended following up with cardiology.No additional adverse patient effects were reported.This crt-d remains in service.Additional information was received and it was reported that this crt-d was reprogrammed and changes were made to medications.No 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.
Additional Manufacturer Narrative
This report is being submitted to update the information in sections b5 and h6.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: 50690741
• Report Number: 2124215-2026-48114
• Device Sequence Number: 5891721
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: (01)00802526534904(17)280421
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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 Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 390411
• 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
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 05/11/2026
• 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: 64 YR
• Patient Sex: Unknown