MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number 4543

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

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058); Sepsis (2067)

Event Date 06/19/2019

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

It was reported that this right ventricular (rv) lead was part of a system revision due to infection with sepsis.There were no additional adverse patient effects reported.The rv lead was explanted.

Event Description

This supplemental report is being filed as an additional code was added.It was reported that this right ventricular (rv) lead was part of a system revision due to infection with sepsis.There were no additional adverse patient effects reported.The rv lead was explanted.

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.

• Brand Name: EASYTRAK 2 IS-1
• 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: 8847632
• MDR Text Key: 152843535
• Report Number: 2124215-2019-15132
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: 00802526410994
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

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: 03/23/2017
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 192591
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR