MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? X4 CRT-D; Cardiac Resynchronization Therapy Defibrillator

Model Number	G158
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient with this cardiac resynchronization therapy defibrillator (crt-d) device was seen that the right ventricular (rv) pace after premature ventricular contraction (pvc) by the health care provider (hcp).Boston scientific technical services reviewed the presenting rhythm and noted that the patient was having pvc's that were falling into cross chamber blanking and sensor was pacing as well and so technical services explained that this was called a functional under sensing.Furthermore, an additional information indicated that this device was explanted.No additional adverse patient effects were reported.The device was returned for analysis.

• 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; 4100 hamline avenue north; saint paul MN 55112 -579
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50190467
• Report Number: 2124215-2026-42575
• Device Sequence Number: 9887560
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: (01)00802526534904(17)190515
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 05/15/2019
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 171169
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2017
• 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: 61 YR
• Patient Sex: Male