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

Model Number	G247
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Fatigue (1849)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with this pacemaker experienced more tiredness than before, the patient alleged requiring pacemaker adjustments.Technical services (ts) was consulted and reviewed possible reasons for the exhibited change, including physiological changes and device optimization options.A temporary interference with sensing was discussed.This pacemaker remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
A good faith effort was performed to obtain additional information.At this time, no further information is available.Should additional information become available this report will be updated.

• Brand Name: VIGILANT? 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: 50818194
• Report Number: 2124215-2026-49921
• Device Sequence Number: 10648537
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: (01)00802526589287(17)211113
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 11/13/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 229143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 11/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male