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

Model Number G247

Device Problems Connection Problem (2900); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2023

Event Type  malfunction  

Manufacturer Narrative

At this time the device has not been returned.Therefore a technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.If the device is returned, product analysis will be completed, and an updated supplemental report will be submitted.

Event Description

It was reported during the implant procedure of this cardiac resynchronization therapy defibrillator (crt-d) device that the left ventricular (lv) lead connection to the device seemed unstable.The physician unscrewed the lv connection in order to retry the attachment.When doing this the setscrew came out of the seal plug.The device was removed, and a new device implanted successfully.Besides surgical intervention, no adverse patient effects were reported.The device is expected to be returned for analysis.

Manufacturer Narrative

Based on all the available information, boston scientific determined the most probable cause of the event was related to an unintended user error.The clinical observations were confirmed through laboratory analysis as the lv set screw is missing from the lv negative terminal block and is stuck on the end of the wrench the was packaged with this device.The observed damage is not deemed to indicate a product defect or malfunction, but based on the analysis finding of induced damage.The instructions for use (ifu) provides additional instructions on how to loosen stuck setscrews if they occur during procedures and reminds users not to back the setscrew out against the backstop.

Event Description

It was reported during the implant procedure of this cardiac resynchronization therapy defibrillator (crt-d) device that the left ventricular (lv) lead connection to the device seemed unstable.The physician unscrewed the lv connection in order to retry the attachment.When doing this the setscrew came out of the seal plug.The device was removed, and a new device implanted successfully.Besides surgical intervention, no adverse patient effects were reported.This device has been returned, and analysis is complete.

• 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: 16455680
• MDR Text Key: 310379161
• Report Number: 2124215-2023-09430
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 299032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other