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

Model Number G247

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.Upon completion of the analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.(b)(4).

Event Description

It was reported that this pacemaker system was surgically explanted and replaced with a new system the same day due to infection.No additional adverse patient effects were reported.This device is expected to be returned.

Event Description

It was reported that this pacemaker system was surgically explanted and replaced with a new system the same day due to infection.No additional adverse patient effects were reported.

Manufacturer Narrative

The product has been received for analysis.Upon completion of the analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.Patient code 3191 captures the reportable event of surgery.The device passed all testing, therefore no problem was detected.In addition, the infection allegation was not confirmed.Infection is a known medical risk when the skin barrier is breached.However, analysis of the returned product is not able to provide relevant information for infection-related allegations.The device history record confirmed that each device meets specifications before release for use.There is no indication the device manufacturing process contributed to the reported complaint.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11233913
• MDR Text Key: 228839910
• Report Number: 2124215-2021-02295
• 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,other
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/08/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 228779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR