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

Model Number G247

Device Problems Failure to Capture (1081); Pacing Problem (1439); Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Obstruction/Occlusion (2422); Electric Shock (2554); Asystole (4442); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/04/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced a ventricular tachycardia (vt) storm and the cardiac resynchronization therapy defibrillator (crt-d) delivered some electric shock, one of the shocks was not converted rhythm.The therapy eventually was exhausted.A defibrillation threshold (dft) testing was performed and it was noted that the commanded shock was successfully delivered for this crt-d.Reprogramming options were performed.However, the patient experienced an occlusion, which led to heart failure.Additionally, it was noted a loss of capture and pacing inhibition greater than 2 seconds.At this time, the crt-d remains in service and no additional adverse patient effects were reported.

Manufacturer Narrative

The patient code was updated due to additional information received.

Event Description

It was reported that the patient experienced a ventricular tachycardia (vt) storm and the cardiac resynchronization therapy defibrillator (crt-d) delivered some electric shock, one of the shocks was not converted rhythm.The therapy eventually was exhausted.A defibrillation threshold (dft) testing was performed and it was noted that the commanded shock was successfully delivered for this crt-d.Reprogramming options were performed.However, the patient experienced an occlusion, which led to heart failure.Additionally, it was noted a loss of capture and pacing inhibition greater than 2 seconds.At this time, the crt-d remains in service and no additional adverse patient effects were reported.

• 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: 15276381
• MDR Text Key: 298406171
• Report Number: 2124215-2022-32069
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

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 Expiration Date: 03/12/2020
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 188431
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• 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
• Patient Age: 76 YR
• Patient Sex: Male