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

Model Number	G247
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced a fall.Technical services (ts) was consulted and noted the presence of far field oversensing of right ventricular (rv) signals on the right atrial (ra) channel, with atrial tachy response (atr) episodes stored.Ts conducted a heart connect session with the local company representative, during which sensitivity adjustments were made and the atr episode criteria settings were modified.This device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• 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: 50602131
• Report Number: 2124215-2026-46871
• Device Sequence Number: 21475323
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: (01)00802526589287(17)230827
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 08/27/2023
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 266565
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 09/02/2021
• 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: Hospitalization
• Patient Age: 84 YR
• Patient Sex: Unknown