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

Model Number G247

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

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 10/09/2023

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had exhibited infection and hematoma.A revision was performed and the crt-d along with the right ventricular (rv) lead, right atrial (ra) lead, left ventricular (lv) lead and previously capped rv lead were explanted.No additional adverse patient effects were reported.This crt-d will be returned for analysis.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had exhibited infection and hematoma.A revision was performed and the crt-d along with the right ventricular (rv) lead, right atrial (ra) lead, left ventricular (lv) lead and previously capped rv lead were explanted.No additional adverse patient effects were reported.This crt-d will be returned for analysis.

Manufacturer Narrative

The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was successfully interrogated and completed a memory dump.Visual inspection found no irregularities with the device, and the header was firmly attached.The longevity calculation for this device passed or was not applicable.The infection or infection related allegation could not be confirmed by laboratory analysis.Infection is a known medical risk when the skin barrier is breached.Analysis of the returned product is not able to provide relevant information for infection-related allegations.

• 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: 18044283
• MDR Text Key: 327016777
• Report Number: 2124215-2023-60880
• 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
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 314221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2023
• 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: 77 YR
• Patient Sex: Female