MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; IMPLANTABLE DEVICE

Model Number G247

Device Problems Defibrillation/Stimulation Problem (1573); Failure to Read Input Signal (1581); Under-Sensing (1661)

Patient Problem Loss of consciousness (2418)

Event Date 01/12/2024

Event Type  malfunction  

Event Description

It was reported that technical services (ts) was contacted by the field representative regarding an episode of ventricular fibrillation (vf) that lasted 40 minutes without shock therapy from the cardiac resynchronization therapy defibrillator (crt-d).The patient reported passing out.Ts reviewed the episode and saw two anti-tachycardia pacing (atp) events, noted some undersensing due to variable amplitudes, but concluded the vf therapy zone needed to be reduced as the vf was not meeting therapy criteria given the current programming.The crt-d system remains in service.No adverse patient effects were reported.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• 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: 18577280
• MDR Text Key: 333773964
• Report Number: 2124215-2024-03842
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 227918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2019
• 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: 72 YR