MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	4525
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067); No Code Available (3191)
Date of Event	04/28/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that this left ventricular (lv) lead was part of a system revision due to infection with sepsis.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The lv lead was surgically abandoned.
Additional 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.Patient code 3191 captures the reportable event of surgery and additional intervention performed as patient was treated with antibiotics.
Event or Problem Description
It was reported that this left ventricular (lv) lead was part of a system revision due to infection with sepsis.The patient has been in the hospital for the past week.The system may be coming out, but no firm plan as of this time.Additional information obtained from the field which indicated that this left ventricular (lv) lead broke during the extraction procedure.The left ventricular (lv) lead was noted to be around the right atrial (ra) lead thus, the physician decided to cap the left ventricular (lv) lead.The patient was treated with antibiotics and once infection will be cleared; the patient will be implanted with a new system.This left ventricular (lv) lead was surgically abandoned.No additional adverse patient effects were reported.

• Brand Name: EASYTRAK 3
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10227535
• Report Number: 2124215-2020-11751
• Device Sequence Number: 11571431
• Product Code: NIK
• UDI-Device Identifier: 00802526353772
• UDI-Public: 00802526353772
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/21/2007
• Device Model Number: 4525
• Device Catalogue Number: 4525
• Device Lot Number: 158714
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR