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

Model Number	G247
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had reached elective replacement indicator (eri) since may and may have been beyond end of life (eol) at this point.Technical services (ts) discussed that there is no guarantee of continued device function so device should be replaced urgently.To date, this device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had reached elective replacement indicator (eri) since may and may have been beyond end of life (eol) at this point.Technical services (ts) discussed that there is no guarantee of continued device function so device should be replaced urgently.To date, this device remains in service.No adverse patient effects were reported.Additional information received indicates that the device was explanted and a new device was successfully placed.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had reached elective replacement indicator (eri) since may and may have been beyond end of life (eol) at this point.Technical services (ts) discussed that there is no guarantee of continued device function so device should be replaced urgently.To date, this device remains in service.No adverse patient effects were reported.Additional information received indicates that the device was explanted and a new device was successfully placed.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This supplemental report was created to capture additional information on b5 event description and h6 impact codes.
Additional Manufacturer Narrative
This supplemental report was created to capture additional information on b5 event description and h6 impact codes.This supplemental report was created to capture correction in b2.

• Brand Name: VIGILANT 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; 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: 50800691
• Report Number: 2124215-2026-49608
• Device Sequence Number: 10589643
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/06/2023
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 273689
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 12/13/2021
• 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; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female