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

Model Number G247

Device Problems Failure to Capture (1081); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d), implanted with another manufacturer's left ventricular (lv) lead, stored left ventricular automatic threshold (lvat) tests with fluctuating threshold measurements.Lv threshold measurements were previously stable at 0.6v and now fluctuated between 1.5 v and 5 v.Additionally, the presenting electrogram (egm) showed suspected lv loss of capture (loc).It was noted that the lv pace vector was reprogrammed from lvtip1>>right ventricle (rv) to lvring1>>rv this past december.Technical services (ts) recommended further device evaluation in clinic.This crt-d system remains in service.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: 18907864
• MDR Text Key: 337748917
• Report Number: 2124215-2024-15665
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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: 285699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• 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: 72 YR
• Patient Sex: Female