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

Model Number	4524
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Unspecified Infection (1930); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	10/07/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EASYTRAK 3
• Common Device Name: 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
• Report Number: 2124215-2022-43606
• Device Sequence Number: 6421581
• Product Code: NIK
• UDI-Device Identifier: 00802526353758
• UDI-Public: 00802526353758
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female