MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number G247

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Date 10/31/2022

Event Type  malfunction  

Event Description

It was reported that the health care professional (hcp) wanted to review an event in which the patient received shocks.Technical services (ts) reviewed the data and found that the cardiac resynchronization therapy defibrillator (crt-d) had delivered inappropriate anti-tachycardia pacing (atp) therapy and inappropriate shock therapy for atrial fibrillation (af) with rapid ventricular response (rvr).Seven inappropriate shocks were delivered in the ventricular tachycardia (vt) zone, and therapy was exhausted.Another inappropriate shock was delivered in the ventricular fibrillation (vf) zone, which converted the af.Another episode of inappropriate therapy triggered by af with rvr occurred again almost two weeks after the original episode.Two inappropriate shocks were delivered.Ts discussed changing the settings in both occurrences.The device remains in use.No adverse patient effects were reported.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15880188
• MDR Text Key: 307704006
• Report Number: 2124215-2022-49688
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/18/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 220945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2019
• 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: 53 YR
• Patient Sex: Male