MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; IMPLANTABLE DEVICE

Model Number G247

Device Problem Failure to Capture (1081)

Patient Problem Asystole (4442)

Event Date 04/27/2023

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had tachy therapy turned off due to comfort care and was do not resuscitate (dnr) status.It was noted that the patient has been hospitalized.Approximately two weeks later the field representative was told by the attending physician to turn tachy therapy on.There were no stored episodes however a week later, there are observations of loss of capture seen on an external electrocardiogram in which the patient had asystole and ventricular fibrillation (vf) that required an external shock.A right ventricular autothreshold (rvat) test was ran and was successful.Technical services reviewed the data and found there were no error coders observed however, there was loss of capture and a very slow escape rate.Additionally, there was a fast wide tachycardia, and the strip says cardiopulmonary resuscitation (cpr) in which the patient had to be resuscitated.Technical services provided troubleshooting options.At this time, the device remains in service.No additional adverse patient effects were reported.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• 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: 16942362
• MDR Text Key: 315333264
• Report Number: 2124215-2023-24350
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/21/2020
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 198474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2018
• 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): Other; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female