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

Model Number G247

Device Problem Defective Device (2588)

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

Event Date 01/03/2024

Event Type  malfunction  

Event Description

It was reported that the communicator displayed a red call doctor icon which indicates a potential issue with the cardiac resynchronization therapy defibrillator (crt-d).Technical services (ts) was contacted for further information.This patient was referred to their health care professional.The cause of the red call doctor icon is unknown at this time.This crt-d remains in-service.No adverse patient effects were reported.

Event Description

It was reported that the communicator displayed a red call doctor icon which indicates a potential issue with the cardiac resynchronization therapy defibrillator (crt-d).Technical services (ts) was contacted for further information.This patient was referred to their health care professional.The cause of the red call doctor icon is unknown at this time.This crt-d remains in-service.No adverse patient effects were reported.Additional information was received.No red alerts were noted on this crt-d.The color of the light on the communicator was likely misinterpreted.No indication of product problem and no adverse patient effects were reported.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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: 18489617
• MDR Text Key: 332924377
• Report Number: 2124215-2024-01096
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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 Expiration Date: 11/29/2019
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 183179
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1