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 Unspecified Infection (1930); Pneumonia (2011); Sepsis (2067)

Event Date 07/23/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the allegation against the device was not confirmed.The device was analyzed, passed all the baseline tests and exhibited normal device functions.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) exhibited septicemia and infecton with pneumonia.A revision was performed and the crt-d along with the right ventricular (rv), right atrial (ra) and left ventricular (lv) leads were explanted.The leads were sent to pathology and the device will be returned.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.The baseline testing completed on the device found no failing conditions.All testing completed on the device passed or was not applicable, therefore no problem was detected.Moreover, the infection allegation could not be confirmed by lab analysis.Further, known inherent risk conclusion code was based on the field report of infection or infection-related conditions.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.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) exhibited septicemia and infecton with pneumonia.A revision was performed and the crt-d along with the right ventricular (rv), right atrial (ra) and left ventricular (lv) leads were explanted.The leads were sent to pathology and the device will be returned.The device was returned and the allegation was not confirmed, as the reported allegations of infection with sepsis were known inherent risk of the device.

• 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
• 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: 12735578
• MDR Text Key: 279536544
• Report Number: 2124215-2021-33285
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2023
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 252811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2021
• 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: 78 YR
• Patient Sex: Male