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

Model Number 4542

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

Patient Problems Death (1802); Unspecified Infection (1930); Staphylococcus Aureus (2058); Fluid Discharge (2686); No Code Available (3191)

Event Date 04/13/2020

Event Type  Death  

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.(b)(4).

Event Description

It was reported that this left ventricular (lv) lead was part of a system revision due to infection.Reportedly, the patient was presenting with one week of bloody, non-purulent discharge and 1-2 cm defect in skin overlying the pacemaker.Initially, there was concern for right ventricular (rv) lead mass, however no valvular or lead vegetation was noted.Moreover, the patient had methicillin-resistant staphylococcus aureus (mrsa) infection.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The lv lead was surgically capped.

Manufacturer Narrative

Patient code 3191 captures the reportable event of surgery and the additional intervention treatment with the use of intravenous antibiotics.

Event Description

It was reported that this left ventricular lead was surgically abandoned due to infection.Following treatment with intravenous antibiotics, the patient was afebrile, hemodynamically stable, without leukocytosis, and without signs of systemic infection.No vegetation was found on the right ventricular lead.The associated device was explanted while the right ventricular and right atrial leads were surgically abandoned due to high risk of lead extraction.Wound cultures showed methicillin-resistant staphylococcus aureus (mrsa).Additional information was received indicating that the patient had expired approximately three months following the procedure.

• 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: 10639788
• MDR Text Key: 210150992
• Report Number: 2124215-2020-19899
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: 00802526410901
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/06/2012
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 141232
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 92 YR
• Patient Weight: 68