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

Model Number	4543
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device remains in service and was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited high out of range pacing impedance measurements.It was also noted that it appeared the threshold had dropped when the impedance went up.Technical services (ts) was consulted and discussed conducting testing in person.This lv lead remains in service and no adverse patient effects were reported.
Additional Manufacturer Narrative
This report is being submitted to update the information in section b5.This device remains in service and was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited high out of range pacing impedance measurements.It was also noted that it appeared the threshold had dropped when the impedance went up.Technical services (ts) was consulted and discussed conducting testing in person.This lv lead remains in service and no adverse patient effects were reported.Additional information was received and it was reported that the device was checked in the clinic and the impedance measurements were not out of range.No 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: 25056729
• Report Number: 2124215-2026-23776
• Device Sequence Number: 21181989
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: (01)00802526410994(17)170206
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 05/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/06/2017
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 190404
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/04/2026
• Date Device Manufactured: 02/06/2015
• 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
• Patient Age: 71 YR
• Patient Sex: Male