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

Model Number G247

Device Problems Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439)

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

Event Date 04/08/2024

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) stored pacemaker mediated tachycardia (pmt) episodes.Upon further review of the episodes, boston scientific technical services (ts) recommended further evaluation of the right atrial (ra) lead due to signals following the atrial pace that could be either far field oversensing or loss of capture (loc).The involved lead is a non boston scientific product.A chest x ray was recommended.No adverse patient effects were reported.At this time, this device system remains in service.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) stored pacemaker mediated tachycardia (pmt) episodes.Upon further review of the episodes, boston scientific technical services (ts) recommended further evaluation of the right atrial (ra) lead due to signals following the atrial pace that could be either far field oversensing or loss of capture (loc).The involved lead is a non boston scientific product.A chest x ray was recommended.Further information was provided that a chest x ray was performed to evaluate atrial lead placement and it was confirmed to be in a good position.It was determined that this patient had a junctional escape rhythm.The physician increased the lower rate from 50 to 60 beats per minute (bpm) and will continue to monitor the patient.No adverse patient effects were reported.At this time, this device system remains in service.

• 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: 19205665
• MDR Text Key: 341486171
• Report Number: 2124215-2024-25810
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 315561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/02/2024
• 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: 77 YR
• Patient Sex: Male