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

Model Number G247

Device Problems Pacing Problem (1439); Inaccurate Synchronization (1609)

Patient Problem Arrhythmia (1721)

Event Date 09/15/2023

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) was experiencing what appears as a tachycardia wide complex paced rhythm.The physician was made aware that presenting rhythm shows more atrial beats than ventricular (v), and it appears that patient is in a slow ventricular tachycardia (vt) that is being bi-v trigger paced because the rate is around 110.Pt has treatment of atp for 130bpm and above.Turning down pace rate to see what rhythm the patient is doing was recommended.No stored events because rates were lower than 130bpm.The crt-d remains in service at this time and there was no asystole nor patient symptoms.No additional adverse patient effects were reported.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) was experiencing what appears as a tachycardia wide complex paced rhythm.The physician was made aware that presenting rhythm shows more atrial beats than ventricular (v), and it appears that patient is in a slow ventricular tachycardia (vt) that is being bi-v trigger paced because the rate is around 110.Pt has treatment of atp for 130bpm and above.Turning down pace rate to see what rhythm the patient is doing was recommended.No stored events because rates were lower than 130bpm.The crt-d remains in service at this time and there was no asystole nor patient symptoms.Additional information was received from medical safety team mentioning it seems patient is in a slow wide complex rhythm that may not even be vt, atrium beats >ventricular beats per complaint, where the device is trigger pacing, does not read as though the trigger pacing induced the rhythm even if it is vt.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 17892888
• MDR Text Key: 325235367
• Report Number: 2124215-2023-55511
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 287672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• 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: 81 YR
• Patient Sex: Male