MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? X4 CRT-D; Implantable Device

Model Number	G156
Medical Device Problem Codes	Over-Sensing (1438); Failure to Read Input Signal (1581); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the field representative called for a review of a stored atrial tachy response (atr) episode for this patient with a cardiac resynchronization therapy defibrillator (crt-d) system.Technical services reviewed the episode, and it appears the patient had ventricular tachycardia (vt) with farfield oversensing on a non-boston scientific right atrial (ra) lead.It was known that farfield oversensing in a known issue for this patient.Ts discussed programming options.At this time, the device remains in service.Additional information was received which reported there is still an ongoing issue with farfield ovesensing.Additionally, p waves are noted to be small therefore, no programming options are available.Ts also noted there was atrial undersensing.At this time, the device and non-boston scientific lead remains in service.No adverse patient effects were reported.This supplemental report is being filed as additional information was received which reported that this device was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the field representative called for a review of a stored atrial tachy response (atr) episode for this patient with a cardiac resynchronization therapy defibrillator (crt-d) system.Technical services reviewed the episode, and it appears the patient had ventricular tachycardia (vt) with farfield oversensing on a non-boston scientific right atrial (ra) lead.It was known that farfield oversensing in a known issue for this patient.Ts discussed programming options.At this time, the device remains in service.Additional information was received which reported there is still an ongoing issue with farfield ovesensing.Additionally, p waves are noted to be small therefore, no programming options are available.Ts also noted there was atrial undersensing.At this time, the device and non-boston scientific lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the field representative called for a review of a stored atrial tachy response (atr) episode for this patient with a cardiac resynchronization therapy defibrillator (crt-d) system.Technical services reviewed the episode, and it appears the patient had ventricular tachycardia (vt) with farfield oversensing on a non-boston scientific right atrial (ra) lead.It was known that farfield oversensing in a known issue for this patient.Ts discussed programming options.At this time, the device remains in service.Additional information was received which reported there is still an ongoing issue with farfield ovesensing.Additionally, p waves are noted to be small therefore, no programming options are available.Ts also noted there was atrial undersensing.At this time, the device and non-boston scientific lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of oversensing was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Based on a thorough review of the reported complaint, the conclusion code no problem detected was selected.--- this supplemental report is being filed as additional information was received which reported that this device was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN? X4 CRT-D
• Common Device Name: Implantable Device
• 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: 24224001
• Report Number: 2124215-2026-05568
• Device Sequence Number: 18459886
• Product Code: NIK
• UDI-Device Identifier: 00802526534669
• UDI-Public: 00802526534669
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/13/2026

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: 08/24/2018
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 373718
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 01/28/2026; 07/24/2026; 08/12/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/02/2026; 08/10/2026; 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2016
• 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: 79 YR
• Patient Sex: Male