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

Model Number G247

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631)

Patient Problem Electric Shock (2554)

Event Date 11/23/2023

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) device received inappropriate shocks.Technical services (ts) reviewed and stated that those shocks were likely atrial driven.There were boundless endless loop tachycardia (belt) rhythms noted.The plan was to refer the patient to the electrophysiology (ep).This device remains in service.No adverse patient effects were reported.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (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: 18239763
• MDR Text Key: 329394815
• Report Number: 2124215-2023-67953
• 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: Physician
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/11/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 231193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2020
• 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): Other
• Patient Age: 86 YR
• Patient Sex: Male