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); Swelling (2091); Fluid Discharge (2686); Swelling/ Edema (4577)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to wound infection.Reportedly the patient presented to the emergency room (er) with complaint of swelling, redness and intermittent draining from incision site a few days after the staples were removed.The patient was prescribed with oral antibiotics for ten days and advised for a follow-up with physician the next day.There were no additional adverse patient effects reported.The crt-d remains in service.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to wound infection.Reportedly the patient presented to the emergency room (er) with complaint of swelling, redness and intermittent draining from incision site a few days after the staples were removed.The patient was prescribed with oral antibiotics for ten days and advised for a follow-up with physician the next day.There were no additional adverse patient effects reported.The crt-d remains in service.Additional information indicated that this cardiac resynchronization therapy defibrillator (crt-d) has been explanted due to infection.There were no additional adverse patient effects reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the allegation against this device was not confirmed.This device was analyzed, passed all the baseline tests and exhibited normal device functions.This supplemental is being filed to capture d9: returned to manufacturer date and investigation results.If information is provided in the future, a supplemental report will be issued.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to wound infection.Reportedly the patient presented to the emergency room (er) with complaint of swelling, redness and intermittent draining from incision site a few days after the staples were removed.The patient was prescribed with oral antibiotics for ten days and advised for a follow-up with physician the next day.There were no additional adverse patient effects reported.The crt-d remains in service.Additional information indicated that this cardiac resynchronization therapy defibrillator (crt-d) has been explanted due to infection.There were no additional adverse patient effects 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: 8519258
• MDR Text Key: 142099717
• Report Number: 2124215-2019-05436
• Device Sequence Number: 1
• Product Code: NIK
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/26/2020
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 204871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2018
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male