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

Model Number G247

Device Problem Failure to Convert Rhythm (1540)

Patient Problem Chest Pain (1776)

Event Date 06/12/2023

Event Type  Injury  

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) failed to convert ventricular fibrillation (vf) after eight shocks.The patient was externally defibrillated and the vf was converted.The patient was hospitalized and programming changes were made.The crt-d system remains in service.No additional 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: 17211036
• MDR Text Key: 317957418
• Report Number: 2124215-2023-33435
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/06/2023
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 252306
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2021
• 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 Outcome(s): Hospitalization
• Patient Age: 50 YR