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

Model Number G247

Device Problems Premature Discharge of Battery (1057); Failure to Capture (1081); Battery Problem (2885); High Capture Threshold (3266)

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

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and right ventricular (rv) defibrillation lead exhibited non-capture at maximum outputs.The battery of this crt-d was suspected to be depleting prematurely due to a longevity estimate of 11 months less than a month after implant.The rv lead also exhibited low out-of-range pace impedance measurements less than 200 ohms.A request was made to have data from this device analyzed.Data analysis appeared consistent with a latent failure of the device pace output with the potential for lead corrosion.Chest x-rays appeared normal.This crt-d and rv lead were explanted, replaced, and returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.Correction to h6: impact code f2203/imaging required added to indicate x-rays were performed.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and right ventricular (rv) defibrillation lead exhibited non-capture at maximum outputs.The battery of this crt-d was suspected to be depleting prematurely due to a longevity estimate of 11 months less than a month after implant.The rv lead also exhibited low out-of-range pace impedance measurements less than 200 ohms.A request was made to have data from this device analyzed.Data analysis appeared consistent with a latent failure of the device pace output with the potential for lead corrosion.Chest x-rays appeared normal.This crt-d and rv lead were explanted, replaced, and returned for analysis.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: 18682333
• MDR Text Key: 335073204
• Report Number: 2124215-2024-07730
• 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,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 321291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2023
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female