MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; IMPLANTABLE LEAD

Model Number	4542
Medical Device Problem Codes	Fracture (1260); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted due to non-specific product performance issue.A new lead was successfully implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted due to non-specific product performance issue.A new lead was successfully implanted.No additional adverse patient effects were reported.Subsequently, additional information was received indicating lv lead had fractured.
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted due to non-specific product performance issue.A new lead was successfully implanted.No additional adverse patient effects were reported.Subsequently, additional information was received indicating lv lead had fractured.
Additional Manufacturer Narrative
This electrode was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.The electrode was returned in two segments, fractured (with complete separation of both the insulation and conductor coils) at approximately 470 mm from the tip end.Visual inspection revealed cracked/torn through both insulations exposing all coils approx.215mm from the tip end -- consistent with environmental over stress.Such damage is considered a design issue when the field report indicates the damage occurred during normal use.

• Brand Name: EASYTRAK 2 IS-1
• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 20889542
• Report Number: 2124215-2024-77831
• Device Sequence Number: 12738403
• Product Code: NIK
• UDI-Device Identifier: 00802526579806
• UDI-Public: 00802526579806
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2025

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: 03/23/2017
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 164958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 12/19/2024; 03/05/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 12/25/2024; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2015
• 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: 73 YR
• Patient Sex: Female