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

Model Number	4542
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited noisy signals, crosstalk oversensing, out of range pacing impedances with measurements greater than 3000 ohms, and loss of capture.Technical services (ts) reviewed the available data and confirmed these observations.Ts also noted that the header has the latest enhancements designed to minimize spring contact related issues, making a connection problem unlikely.Further in clinic evaluation was recommended.No adverse patient effects were reported, and this lv lead remains in service.
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited noisy signals, crosstalk oversensing, out of range pacing impedances with measurements greater than 3000 ohms, and loss of capture.Technical services (ts) reviewed the available data and confirmed these observations.Ts also noted that the header has the latest enhancements designed to minimize spring contact related issues, making a connection problem unlikely.Further in clinic evaluation was recommended.No adverse patient effects were reported, and this lv lead remains in service.Additional information indicated that the root cause may be related to the ring electrode, they reprogrammed lv pacing configuration tip to the device and confirmed these observations are only attributed to this lv lead.

• Brand Name: EASYTRAK 2 IS-1
• Common Device Name: IMPLANTABLE ELECTRODE
• 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: 24036205
• Report Number: 2124215-2026-01783
• Device Sequence Number: 10277131
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: (01)00802526410901(17)131221
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2026

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: 12/21/2013
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 150877
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 06/10/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/16/2026; 06/11/2026
• Date Device Manufactured: 12/21/2011
• 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
• Patient Age: 81 YR
• Patient Sex: Male