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

Model Number G247

Device Problems High impedance (1291); Over-Sensing (1438); Connection Problem (2900)

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

Event Date 03/25/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited pacing lead impedance (pli) measurements of the right atrial (ra) lead that were greater than 3000 ohms, which was out-of-range.It was suspected that there was a disconnection with the spring contact with this device header.The ra lead is a non-boston scientific product.Technical services (ts) analyzed the presenting electrogram (egm) and found that there was a signal artifact monitoring (sam) episode with respiratory rate trend (rrt) noise on the ra channel and oversensing that resulted in a respiratory sensor vector switch.Ts recommended a chest x-ray and further testing.Patient was tested in clinic but the clinical observations were not reproduced.It was noted that this will be further monitored.No adverse patient effects were reported.Currently, this crt-d remains in service.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the respiratory sensor that is related to intermittent increases in impedance measurements.Additionally, engineering analysis and testing of returned products has identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time.This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements.Please refer to the description field for more information regarding the specific circumstances of this event.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited pacing lead impedance (pli) measurements of the right atrial (ra) lead that were greater than 3000 ohms, which was out-of-range.It was suspected that there was a disconnection with the spring contact with this device header.The ra lead is a non-boston scientific product.Technical services (ts) analyzed the presenting electrogram (egm) and found that there was a signal artifact monitoring (sam) episode with respiratory rate trend (rrt) noise on the ra channel and oversensing that resulted in a respiratory sensor vector switch.Ts recommended a chest x-ray and further testing.Patient was tested in clinic but the clinical observations were not reproduced.It was noted that this will be further monitored.No adverse patient effects were reported.Currently, this crt-d remains in service.

• 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: 16708530
• MDR Text Key: 313039554
• Report Number: 2124215-2023-16583
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/19/2020
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 187191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2018
• 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 Age: 74 YR
• Patient Sex: Female