MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number G248

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); High Capture Threshold (3266)

Patient Problem Dizziness (2194)

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this system with a right ventricular (rv) lead and a cardiac resynchronization therapy defibrillator (crt-d) recorded a rv automatic threshold detected as greater then programmed amplitude or suspended, alert.It was identified that the alert was related to high pacing thresholds without safety margin and loss of capture (loc) was suspected.Also, it was noted that the crt-d recorded two false positive signal artifact monitoring episodes due to a ventricular tachycardia ablation procedure.It was recommended to bring the patient back so the respiratory rate trend could be turned back on and to adjust the rv outputs according with a better safety margin.The patient had been having some intermittent lightheadedness.The crt-d and rv lead remain in service.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this system with a right ventricular (rv) lead and a cardiac resynchronization therapy defibrillator (crt-d) recorded a rv automatic threshold detected as greater than programmed amplitude or suspended, alert.It was identified that the alert was related to high pacing thresholds without safety margin and loss of capture (loc) was suspected.Also, it was noted that the crt-d recorded two false positive signal artifact monitoring episodes due to a ventricular tachycardia ablation procedure.It was recommended to bring the patient back so the respiratory rate trend could be turned back on and to adjust the rv outputs according with a better safety margin.The patient had been having some intermittent lightheadedness.The rv lead remains in service and the crt-d has been explanted and returned for analysis.No additional adverse patient effects were reported.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 18451834
• MDR Text Key: 332280572
• Report Number: 2124215-2023-75317
• Device Sequence Number: 1
• Product Code: NIK
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/02/2019
• Device Model Number: G248
• Device Catalogue Number: G248
• Device Lot Number: 376506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2017
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male