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

Model Number	4542
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort was performed to obtain additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted due to a non-product experience.A new device was implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
A good faith effort was performed to obtain additional information.At this time, no further information is available.Should additional information become available this report will be updated.Additional information from the field indicates this lead was explanted due to a therapy upgrade.There were no issues.No additional adverse patient effects were reported.No report was required for this device.
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted due to a non-product experience.A new device was implanted.No additional adverse patient effects were reported.Additional information from the field indicates this lead was explanted due to a therapy upgrade.There were no issues.No additional adverse patient effects were reported.

• 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: 22946008
• Report Number: 2124215-2025-61581
• Device Sequence Number: 18429497
• Product Code: NIK
• UDI-Device Identifier: 00802526579806
• UDI-Public: (01)00802526579806(17)170401
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 04/01/2017
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 306864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/05/2025
• Date Device Manufactured: 04/01/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male