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

Model Number	G248
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); High Capture Threshold (3266)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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 or Problem 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.
Event or Problem 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.
Additional 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.

• Brand Name: VIGILANT X4 CRT-D
• Common Device Name: 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
• Report Number: 2124215-2023-75317
• Device Sequence Number: 12707994
• Product Code: NIK
• UDI-Device Identifier: 00802526589300
• UDI-Public: 00802526589300
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2024

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
• Operator of Device: 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 04/24/2024; 05/28/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 05/15/2024; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male