MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3; IMPLANTABLE PACING LEAD

Model Number	4525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Vascular Dissection (3160); No Code Available (3191)
Date of Event	01/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that this patient underwent an extraction procedure to remove a cardiac resynchronization therapy defibrillator (crt-d) device and the associated leads, due to an infection.During removal of the left ventricular (lv) lead using laser technology, the coronary sinus was badly torn and required an urgent surgical intervention.The patient survived but was placed on extracorporeal membrane oxygenation (ecmo).The explanted products were not intended to be returned.

• Brand Name: EASYTRAK 3
• Common Device Name: IMPLANTABLE PACING LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10021446
• Report Number: 2124215-2020-09819
• Device Sequence Number: 16823132
• Product Code: NIK
• UDI-Device Identifier: 00802526353772
• UDI-Public: 00802526353772
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010012/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/17/2005
• Device Model Number: 4525
• Device Catalogue Number: 4525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 05/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR