MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2

Model Number 4518

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

Patient Problems Cardiomyopathy (1764); Congestive Heart Failure (1783); Purulent Discharge (1812); Unspecified Infection (1930); Complete Heart Block (2627)

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

Common device name defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d).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

Boston scientific received information that this left ventricular (lv) lead was part of a system revision due to infection.The patient also had a dilated cardiomyopathy, congestive heart failure and complete heart block.Upon opening the pocket site, a purulent material was noted.The pocket was debrided from the necrotic tissue and flushed with antibiotics solution.The patient was also treated with antibiotics ointment.There were no additional adverse patient effects reported.The lv lead was explanted.

Manufacturer Narrative

Common device name: defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d).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

This supplemental report is being filed as updates from product investigation was received.Boston scientific received information that this left ventricular (lv) lead was part of a system revision due to infection.The patient also had a dilated cardiomyopathy, congestive heart failure and complete heart block.Upon opening the pocket site, a purulent material was noted.The pocket was debrided from the necrotic tissue and flushed with antibiotics solution.The patient was also treated with antibiotics ointment.There were no additional adverse patient effects reported.The lv lead was explanted.

• Brand Name: EASYTRAK 2
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): GUIDANT PUERTO RICO, B.V.; no. 12, road 698; ,; dorado PR 00646 3311
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8084544
• MDR Text Key: 127574570
• Report Number: 2124215-2018-61000
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526417672
• UDI-Public: 00802526417672
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2010
• Device Model Number: 4518
• Device Catalogue Number: 4518
• Device Lot Number: 332219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 75