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 Codes	Dyspnea (1816); Syncope/Fainting (4411)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device 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 system with a left ventricular (lv) lead and cardiac resynchronization therapy defibrillator (crt-d) recorded unstable pacing impedances (pi) that have reached high, out of range values.Patient felt shortness of breath and syncopal when pacing impedance values were out of range.Thresholds were stable on days when pi was oor and channel was absent of noise.Presenting electrograms unchanged.It was recommended to consider serial impedances with isometric movements if not performed yet and evaluate ring configurations.As patient is not dependent and rv stable, so can continue to monitor the lv and crt-d that remain in service.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: 25010333
• Report Number: 2124215-2026-22766
• Device Sequence Number: 9655492
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: (01)00802526410994(17)150708
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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
• Report Date (Section B): 04/27/2026

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: 07/08/2015
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 183576
• 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: 04/07/2026
• Initial Report FDA Received Date: 04/27/2026
• Date Device Manufactured: 07/08/2013
• 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: Other
• Patient Age: 46 YR
• Patient Sex: Male