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

Model Number G247

Device Problems Over-Sensing (1438); Pacing Problem (1439); Under-Sensing (1661)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

It was reported that this patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced ventricular fibrillation (vf) in which undersensing was observed.This patient has a left ventricular assist device that was possibly being oversensed by the left ventricular (lv) lead.Previous episodes of pacemaker mediated tachycardia (pmt) were observed.The field representative noted there was an episode the same day with ventricular tachycardia (vt) which was successfully converted with anti-tachycardia pacing (atp).Technical services (ts) discussed algorithms and programming with the field representative along with suggesting reviewing with the electrophysiology to confirm if they want to adjust sensitivity, rate count or adjust the lv lead position.Ts noted this may be limited due to low r wave amplitude, patient condition, lvad and oversensing of lvad.This crt-d remains in service.No adverse patient effects were reported.

Manufacturer Narrative

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

• 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: 18978646
• MDR Text Key: 338604346
• Report Number: 2124215-2024-18141
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/04/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 210956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2019
• 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: 47 YR
• Patient Sex: Male