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

Model Number G247

Device Problems Over-Sensing (1438); Pacing Problem (1439); Off-Label Use (1494); High Capture Threshold (3266)

Patient Problems Bradycardia (1751); Fall (1848); Syncope/Fainting (4411)

Event Date 06/05/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited high capture thresholds on the right and left ventricular channels.The patient experienced syncope and "crashed".The patient was hospitalized.Additionally, the patient experienced bradycardia.It was noted that the patient had a cardiac resynchronization therapy pacemaker (crt-p) implanted also but was programmed off.A chest x-ray was performed.There were no lead position changes.It was noted that all reports look normal.This device did not exhibit oversensing or pacing inhibition.The device remains in use.No adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited high capture thresholds on the right and left ventricular channels.The patient experienced syncope and "crashed".The patient was hospitalized.Additionally, the patient experienced bradycardia.It was noted that the patient had a cardiac resynchronization therapy pacemaker (crt-p) implanted also but was programmed off.A chest x-ray was performed.There were no lead position changes.It was noted that all reports look normal.This device did not exhibit oversensing or pacing inhibition.The device remains in use.No adverse patient effects were reported.Additional information received provides clarification on the event.The patient had a syncopal episode and was involved in a car accident as a result.The patient was hospitalized.It was noted that there was lead interaction between the crt-d and crt-p.The crt-d, in turn, exhibited oversensing and pacing inhibition.At the time of the event, the crt-d was turned on, and the crt-p had pacing therapy turned off but had sensing on right ventricular (rv) channel.Subsequently, the crt-d has been turned off, and the crt-p is currently on and is pacing the patient appropriately.The patient was discharged with a wearable defibrillator and has not experienced syncope since.A lead revision is planned at a later date.No additional adverse patient effects were reported.

Manufacturer Narrative

Correction to field b5: describe event or problem correction to field h6: impact code correction to field h6:device code.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited high capture thresholds on the right and left ventricular channels.The patient experienced syncope and "crashed".The patient was hospitalized.Additionally, the patient experienced bradycardia.It was noted that the patient had a cardiac resynchronization therapy pacemaker (crt-p) implanted also but was programmed off.A chest x-ray was performed.There were no lead position changes.It was noted that all reports look normal.This device did not exhibit oversensing or pacing inhibition.The device remains in use.No adverse patient effects were reported.Additional information received provides clarification on the event.The patient had a syncopal episode and was involved in a car accident as a result.The patient was hospitalized.It was noted that there was lead interaction between the crt-d and crt-p.The crt-d, in turn, exhibited oversensing and pacing inhibition.At the time of the event, the crt-d was turned on, and the crt-p had pacing therapy turned off but had sensing on right ventricular (rv) channel.Subsequently, the crt-d has been turned off, and the crt-p is currently on and is pacing the patient appropriately.The patient was discharged with a wearable defibrillator and has not experienced syncope since.A lead revision is planned at a later date.No additional adverse patient effects were reported.Additional information indicates that this device was originally implanted on the right side of the patient.A device revision occurred, which moved the device from the right side to the left side of the patient.The device that was implanted on the left side of the patient was explanted.No additional adverse patient effects were reported.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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: 17292303
• MDR Text Key: 318739650
• Report Number: 2124215-2023-36051
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2023

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: 302936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 07/24/2023; 07/28/2023
• Supplement Dates FDA Received: 07/25/2023; 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• 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: 79 YR
• Patient Sex: Male