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

Model Number	G248
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited a loss of capture on the left ventricular (lv) channel.The loss of capture was observed after the patient received appropriate shock therapy for ventricular tachycardia (vt).After the shock, the device delivered biventricular (biv) pacing, and the loss of capture was observed after the biv pacing.It was reported the patient was hospitalized.This crt-d remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited a loss of capture on the left ventricular (lv) channel.The loss of capture was observed after the patient received appropriate shock therapy for ventricular tachycardia (vt).After the shock, the device delivered biventricular (biv) pacing, and the loss of capture was observed after the biv pacing.It was reported the patient was hospitalized.This crt-d remains in service.No additional adverse patient effects were reported.Additional information was received.The loss of capture was caused by being programmed close to the threshold due to diaphragmatic stimulation, which was bothersome to the patient.The patient was discharged from the hospital and has an appointment scheduled for the future.It was planned to optimize lv output to avoid diaphragmatic stimulation at the appointment.
Additional Manufacturer Narrative
Additional information added to b5.F10 and h6 updated.This product investigation is still in progress.This report will be updated when product investigation is complete.

• 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 PR ; PR
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25486751
• Report Number: 2124215-2026-31544
• Device Sequence Number: 10395214
• Product Code: NIK
• UDI-Device Identifier: 00802526589300
• UDI-Public: (01)00802526589300(17)220205
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2026

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: 02/05/2022
• Device Model Number: G248
• Device Catalogue Number: G248
• Device Lot Number: 384747
• 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: 05/20/2026
• Supplement Date Received by Manufacturer: 06/12/2026; 08/13/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 06/16/2026; 08/14/2026
• Date Device Manufactured: 03/05/2020
• 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
• Patient Sex: Male