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

Model Number G247

Device Problems Failure to Convert Rhythm (1540); Under-Sensing (1661)

Patient Problems Cardiac Arrest (1762); Loss of consciousness (2418); No Code Available (3191)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this patient arrived at the emergency room (er) unresponsive and cardiopulmonary resuscitation (cpr) was performed.A review of the data from the patients cardiac resynchronization therapy defibrillator (crt-d) device indicated that the they experienced three (3) ventricular episodes on that day.All three (3) episodes exhibited device undersensing of the patients fine ventricular fibrillation (vf) arrhythmia.In one (1) of the episodes, anti-tachycardia pacing (atp) therapy was delivered by the device and then the episode ended but it appears that the patient was still exhibiting a fine vf arrhythmia that was being undersensed by the device.A review of the information and a consultation with electrophysiologists (eps) occurred and the device was subsequently reprogrammed later that day according to the direction of the eps.The device remains in-service.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 is being used to capture the additional intervention of cardiopulmonary resuscitation (cpr).

Event Description

It was reported that this patient arrived at the emergency room (er) unresponsive and cardiopulmonary resuscitation (cpr) was performed.A review of the data from the patients cardiac resynchronization therapy defibrillator (crt-d) device indicated that they experienced three (3) ventricular episodes on that day.All three (3) episodes exhibited device undersensing of the patients fine ventricular fibrillation (vf) arrhythmia.In one (1) of the episodes, anti-tachycardia pacing (atp) therapy was delivered by the device and then the episode ended but it appears that the patient was still exhibiting a fine vf arrhythmia that was being undersensed by the device.A review of the information and a consultation with electrophysiologists (eps) occurred and the device was subsequently reprogrammed later that day according to the direction of the eps.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
• MDR Report Key: 10278389
• MDR Text Key: 198948994
• Report Number: 2124215-2020-13916
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2020
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 205596
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR