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

Model Number G247

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Swelling (2091); No Code Available (3191)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to infection.Reportedly, the pocket appeared swollen.It was uncertain if infection or long-standing hematoma, so the doctor elected to extract the system.However additional information received indicates that the system was indeed explanted due to infection.There were no additional adverse patient effects reported.The crt-d was explanted.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had an infection.A revision was performed and the crt-d with the right atrial (ra) lead, right ventricular (rv) lead and left ventricular (lv) lead were explanted.Reportedly, the pocket appeared swollen.It was uncertain if infection or long-standing hematoma, so the doctor elected to extract the system.However additional information received indicates that the system was indeed explanted due to infection.The device and leads were clear, and the leads were sent to pathology for cultures while the device was kept by the hospital and then was returned.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.Patient code 3191 captures the reportable event of surgery.Correction on h3 device eval by manufacturer, h6 patient code and evaluation conclusion code.

• 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
• MDR Report Key: 11191020
• MDR Text Key: 227499014
• Report Number: 2124215-2021-00864
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/12/2020
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 206176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR