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

Model Number	G247
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered anti-tachycardia pacing (atp) and shocks due to a suspected atrial originated arrhythmia with rapid ventricular response (rvr) resulting in therapy exhaustion.Additionally, it was inquired whether a shock was delivered on a t wave.Technical services (ts) reviewed the episode and discussed that the large deflection was not the shock but a deflection of where the sense amplifiers are turned back on.The shock was given at the marker shortly after the qrs complex.Ts provided programming recommendations.No additional adverse patient effects were reported.This device remains in service.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered anti-tachycardia pacing (atp) and shocks due to a suspected atrial originated arrhythmia with rapid ventricular response (rvr) resulting in therapy exhaustion.Additionally, it was inquired whether a shock was delivered on a t wave.Technical services (ts) reviewed the episode and discussed that the large deflection was not the shock but a deflection of where the sense amplifiers are turned back on.The shock was given at the marker shortly after the qrs complex.Ts provided programming recommendations.No additional adverse patient effects were reported.This device remains in service.Additional information was provided indicating that programming parameters were adjusted.No additional adverse patient effects were reported.This device remains in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Additional Manufacturer Narrative
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 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: 50738159
• Report Number: 2124215-2026-48795
• Device Sequence Number: 18791592
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: (01)00802526589287(17)230122
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: 01/22/2023
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 253402
• 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: 09/01/2026
• Supplement Date Received by Manufacturer: 09/13/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 02/04/2021
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Unknown