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); No Code Available (3191)

Event Date 12/21/2020

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.The patient was treated with intravenous antibiotics.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 infection.Reportedly, the patient had mechanical valve on blood thinners with high international normalized ratio (inr) which resulted to hematoma in the pocket.The hematoma evacuation for several times had caused infection.The patient was treated with intravenous antibiotics.The device was explanted.There were no additional adverse patient effects reported.

Manufacturer Narrative

This supplemental report was created to capture the correction on b5: describe event or problem.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.Patient code 3191 captures the reportable event of surgery and the additional intervention performed by the use of intravenous antibiotics.The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.The analysis showed that the device passed all baseline testing and found to anomaly.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had infection.Reportedly, the patient had mechanical valve on blood thinners with high international normalized ratio (inr) which resulted to hematoma in the pocket.The hematoma evacuation for several times had caused infection.The patient was treated with intravenous antibiotics.The device was explanted.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
• MDR Report Key: 11228113
• MDR Text Key: 241236380
• Report Number: 2124215-2021-01823
• 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,Followup
• Report Date: 05/04/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/22/2022
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 247988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 12/22/2020; 03/03/2021
• Supplement Dates FDA Received: 01/26/2021; 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR