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

Model Number G247

Device Problems Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 07/07/2023

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillators (crt-d) device exhibited inappropriate shock and was asymptomatic with the rhythm.Emergency medical service (ems) placed a magnet over the device; however, no shock was reported at that time.The health care professionals wanted to see if interrogation with magnet was available.Technical services confirmed with hcp that they can interrogate the device with a magnet in place.This device remains in service.Additional information received indicated that therapy was exhausted in the vt zone.No adverse patient effects were reported.

Manufacturer Narrative

This report contains additional information in section b5 describe event or problem.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillators (crt-d) device exhibited inappropriate shock and was asymptomatic with the rhythm.Emergency medical service (ems) placed a magnet over the device; however, no shock was reported at that time.The health care professionals wanted to see if interrogation with magnet was available.Technical services confirmed with hcp that they can interrogate the device with a magnet in place.This device remains in service.Additional information received indicated that therapy was exhausted in the vt zone.No adverse patient effects were reported.Additional information received indicated that this device delivered anti-tachycardia pacing (atp) and 6 inappropriate shocks due to supra ventricular tachycardia (svt).The rhythm was converted and became stable.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: 17302863
• MDR Text Key: 318829857
• Report Number: 2124215-2023-36500
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 08/18/2023

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 308783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2023
• 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; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male