MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? X4 CRT-D; IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number	G156
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pocket Erosion (2013)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.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 of device.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted due to erosion.A new device is expected to be implanted.No additional adverse patient effects were reported.This crt-d is no longer in service.

• Brand Name: DYNAGEN? X4 CRT-D
• Common Device Name: IMPLANTABLE 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25244011
• Report Number: 2124215-2026-27474
• Device Sequence Number: 10623323
• Product Code: NIK
• UDI-Device Identifier: 00802526534669
• UDI-Public: (01)00802526534669(17)210326
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: 03/26/2021
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 382324
• 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: 05/18/2026
• Initial Report FDA Received Date: 05/21/2026
• Date Device Manufactured: 04/05/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male