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

Model Number 4524

Device Problem Fracture (1260)

Patient Problems Cardiac Arrest (1762); Unspecified Infection (1930); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/07/2022

Event Type  Injury  

Event Description

It was reported that the patient with this right atrial (ra) lead exhibited infection.Reportedly, while performing right ventricular (rv) lead extraction, the left ventricular (lv) lead was fractured and the coil unraveled; hence, the lv lead was abandoned for the time being.Moreover, while pulling out the right atrial (ra) lead, the anesthesiologist noticed an effusion in the right atrium and the patient experienced cardiac arrest.Cardiopulmonary resuscitation (cpr) was performed.Subsequently, an open-heart procedure was done to fix the effusion.A revision was performed and the cardiac resynchronization therapy defibrillator (crt-d) along with the right ventricular (rv) lead and right atrial (ra), and left ventricular (lv) leads were explanted.There were no adverse patient effects reported.The lv lead will not be returned.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: EASYTRAK 3
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15671040
• MDR Text Key: 302396448
• Report Number: 2124215-2022-43606
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526353758
• UDI-Public: 00802526353758
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010012/S025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/23/2013
• Device Model Number: 4524
• Device Catalogue Number: 4524
• Device Lot Number: 165467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2011
• 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; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female