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

Model Number G247

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Use of Device Problem (1670)

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

It was reported that the right ventricular (rv) defibrillation lead of this cardiac resynchronization therapy defibrillator (crt-d) system recently underwent a lead revision.Following the lead revision, it was determined that the crt-d stored inappropriately stored signal artifact monitor (sam) episodes and disabled the respiratory rate trend (rrt) due to out-of-range pace impedance measurements and oversensed noise at the time of the lead revision.Technical services (ts) reviewed troubleshooting options and programming considerations.This crt-d system remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

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

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.Correction to b5; event description edited to include high shock impedance measurements during lead revision.

Event Description

It was reported that the right ventricular (rv) defibrillation lead of this cardiac resynchronization therapy defibrillator (crt-d) system recently underwent a lead revision.Following the lead revision, it was determined that the crt-d stored inappropriately stored signal artifact monitor (sam) episodes and disabled the respiratory rate trend (rrt) due to out-of-range pace and shock impedance measurements and oversensed noise at the time of the lead revision.Technical services (ts) reviewed troubleshooting options and programming considerations.This crt-d system remains in service.No additional adverse patient effects were reported.

• 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: 18179439
• MDR Text Key: 328629443
• Report Number: 2124215-2023-65632
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 315468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• 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: 89 YR
• Patient Sex: Male