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 Purulent Discharge (1812); Ecchymosis (1818); Edema (1820); Unspecified Infection (1930); Sepsis (2067)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, an analysis of the device was performed.The device passed all testing and had found no failing conditions.Laboratory analysis revealed that the allegation against the device was not confirmed.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of system revision due to infection with sepsis.The patient was given intravenous antibiotics and cultures were obtained.Additionally, the patient was presented to the clinic with mild edema, ecchymosis and drainage at the device wound.Furthermore, the patient was then started with oral antibiotics.The device was explanted.No additional adverse patient effects were reported.

• 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: 9550848
• MDR Text Key: 173756890
• Report Number: 2124215-2019-26745
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/26/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 214921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2019
• 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; Life Threatening; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 64