MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; IMPLANTABLE DEVICE

Model Number G247

Device Problems Pacing Problem (1439); Inaccurate Synchronization (1609)

Patient Problem Ventricular Tachycardia (2132)

Event Date 04/27/2020

Event Type  Injury  

Event Description

It was reported that bi-ventricular pacing therapy delivered by this cardiac resynchronization therapy defibrillator (crt-d) device into a right ventricular (rv) intrinsic beat triggered a non-sustained ventricular tachycardia (vt) episode in this patient.The patient was also noted to exhibit premature ventricular contraction (pvc) beats.Boston scientific technical services (ts) advised to program off the bi-ventricular trigger or decrease the maximum pacing rate (mpr).The device remains in-service.No additional adverse patient effects were reported.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10329564
• MDR Text Key: 200588366
• Report Number: 2124215-2020-15634
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2020

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: 11/30/2020
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 205175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR