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

Model Number	4543
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the left ventricular (lv) lead was misplaced.The lv lead was explanted, and a new lead of a different model was successfully implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This report is being submitted to correct the bsc aware date field (g3) in section g, all manufacturers.
Event or Problem Description
It was reported that the left ventricular (lv) lead was misplaced.The lv lead was explanted, and a new lead of a different model was successfully implanted.No additional adverse patient effects were reported.Additional information received which indicates that during this procedure, the patient had a contrast allergy and visualization of the actual placement was not possible that time.Furthermore, a lead dislodgement was then suspected.
Event or Problem Description
It was reported that the left ventricular (lv) lead was misplaced.The lv lead was explanted, and a new lead of a different model was successfully implanted.No additional adverse patient effects were reported.Additional information received which indicates that during this procedure, the patient had a contrast allergy and visualization of the actual placement was not possible that time.Furthermore, a lead dislodgement was then suspected.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, visual inspection of the lead was performed.Visual inspection revealed no abnormalities.Laboratory testing did not identify any lead characteristics that would have resulted in the clinical observation of dislodgement.No lead issues were noted that would have made dislodgement more likely than what is described in the instructions for use as a known inherent risk of the use of this product.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of dislodged or dislocated was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk.This report is being submitted to correct the bsc aware date field (g3) in section g, all manufacturers.

• 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: 24389227
• Report Number: 2124215-2026-09302
• Device Sequence Number: 16107678
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: (01)00802526410994(17)141126
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2026

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: 11/26/2014
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 177929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 01/08/2026; 06/05/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/24/2026; 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2012
• 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: 63 YR
• Patient Sex: Female