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

Model Number G247

Device Problems Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 03/01/2019

Event Type  malfunction  

Event Description

It was reported that after a therapy upgrade procedure this cardiac resynchronization therapy defibrillator (crt-d) system exhibited noise and oversensing on the right ventricular (rv) lead, which resulted in pacing inhibition.The patient experienced greater than 2 seconds of asystole.Boston scientific technical services (ts) discussed the noise was likely due to air bubbles and would dissipate as the air expelled and the fluid dried.The physician elected to continue to monitor and reprogrammed the device to provide asynchronous pacing and tachy therapy off.Subsequently, the device was checked and no noise was seen.This crt-d system was reprogrammed and remains in service.No adverse patient effects were reported.

Event Description

This supplemental report is being filed as the conclusion code was updated.

• 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
• MDR Report Key: 8512300
• MDR Text Key: 141911681
• Report Number: 2124215-2019-05696
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/15/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 207699
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR