MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G247

Device Problems Failure to Capture (1081); Pacing Problem (1439)

Patient Problem Asystole (4442)

Event Date 02/18/2024

Event Type  malfunction  

Event Description

It was reported that during a device replacement procedure after removing the leads one by one and connect to the new device (g247/294818) to avoid asystole as the patient had complete heart block, the right ventricular lead was connected to the new device and was pacing normally.Then the left ventricular lead was removed from the old device (g148) and connected to the new device.Once the left ventricular lead was connected pacing stopped in both leads and the patient went asystole.One of the leads was removed from the new device and pacing resumed.Oversensing was suspected.The sensing floor was adjusted to maximum and stopping the left ventricular sensing while increasing output to maximum did not solve the problem.The device was programmed to voo mode which did not show any improvement.When the left ventricular lead was connected to the new device and then connecting the left ventricular lead resulted in the same problem.The old device was completely removed, and a pacing system analyzer was used to keep the patient paced in one lead while connecting the other lead to the new device.When connecting one lead to the new device the device was pacing and capturing but removing the other lead from the analyzer and connecting to the new device cause the same problem.No connection issue was seen.There was no issue when the leads were connected to the old device.It was suspected there was a malfunction with the new device.Thus, another device (g247/319839) was used but the same problem occurred.The old device was then interrogated, the same settings were used from the old device (g148) to the new device (g247/319839) and then no pacing issues occurred this time and the device functioned normally.It was suspected that the issue was related to the left ventricular pace/sense vector difference in the old versus the new device.Sensing and/or pacing from a non-viable left ventricular vector causing loss of capture and inhibition on the right ventricular lead.No adverse patient effects were reported.The device g247/294818 was expected to be returned for analysis, while (g247/319839) remained implanted.Reference tw 17873674 for information regarding device g247/294818.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH 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: 18758981
• MDR Text Key: 336005548
• Report Number: 2124215-2024-10603
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: MU
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 319839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1