MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G247

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Off-Label Use (1494)

Patient Problem Asystole (4442)

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a device changeout procedure from another manufacturer's biventricular (biv) implantable cardioverter defibrillator (icd) to this cardiac resynchronization therapy defibrillator (crt-d), left ventricular (lv) pacing inhibition was observed for an unspecified duration once the chronic lv lead was connected to the new device.It was noted that the lv was programmed from lv1>rv on the previous device, and was then programmed to 3>4 for pacing on the crt-d.It was determined that the crt-d was not placed in electrocautery mode, resulting in oversensing and pacing inhibition due to electromagnetic interference (emi) from the procedure.The patient was pacer dependent with no escape rhythm.The lead configuration was confirmed as appropriate, and the procedure was completed successfully.This crt-d system remains in service, and the patient will continue to be monitored remotely.No adverse patient effects were reported.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16354548
• MDR Text Key: 309403660
• Report Number: 2124215-2023-06010
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 291736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male