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

Model Number G247

Device Problems Over-Sensing (1438); Pacing Problem (1439); High Capture Threshold (3266)

Patient Problems Undesired Nerve Stimulation (1980); Asystole (4442)

Event Date 04/08/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded episodes with far field over sensing of the atrial pacing on the right ventricular (rv) lead channel.There was pacing inhibition of more than 3 seconds in the presenting electrogram.Various reprogramming options were completed, and the pacing inhibition was reduced.Other programming options were recommended as well as a defibrillation threshold (dft) test and a chest x ray to confirm lead location.The patient is pacing dependent, and the crt-d remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

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

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded episodes with far field over sensing of the atrial pacing on the right ventricular (rv) lead channel.There was pacing inhibition of more than 3 seconds in the presenting electrogram.Various reprogramming options were completed, and the pacing inhibition was reduced.Other programming options were recommended as well as a defibrillation threshold (dft) test and a chest x ray to confirm lead location.The patient is pacing dependent, and the crt-d remains in service.No additional adverse patient effects were reported.Additional information was received mentioning that false atrial tachy response episodes were recorded with what appears to be far field r wave over sensing post ventricular pacing.The pacing thresholds were high in different coils of the left ventricular (lv) lead.Also, an impedance jump was observed but this was expected behavior due to the surface area size difference.The patient referred feeling some intensity in the pacing.Various reprogramming options were recommended.The crt-d and the lv lead remains in service.No 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: 16851733
• MDR Text Key: 314351806
• Report Number: 2124215-2023-21035
• 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: 06/07/2023

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 Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 302172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male