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

Model Number	G156
Medical Device Problem Codes	High impedance (1291); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis; 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.This investigation will be updated should pertinent information become available in the future.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system delivered inappropriate anti-tachycardia pacing (atp) therapy and a shock for a possible rapid ventricular response (rvr) rhythm due to an atrial arrhythmia.Technical services (ts) was consulted and upon data review identified high out of range shock lead impedance measurements over 137 ohms; as well as pacemaker mediated tachycardia (pmt) episodes.This crtd remains in service.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 ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 24509940
• Report Number: 2124215-2026-12165
• Device Sequence Number: 10486539
• Product Code: NIK
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: 07/04/2020
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 380483
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 07/19/2018
• 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: 53 YR
• Patient Sex: Female