MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number	4543
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this left ventricular (lv) lead recorded high out of range pacing impedance measurements.Technical services (ts) reviewed the device data and recommended the lv lead replacement.No adverse patient effects were reported.This lv lead remains in service.
Additional Manufacturer Narrative
Follow up report 1 (additional information): this report is being submitted to update field b5: describe event or problem, section b and field h6: device and impact codes, section h.
Event or Problem Description
It was reported that this left ventricular (lv) lead recorded high out of range pacing impedance measurements during an in-clinic visit.Technical services (ts) reviewed the device data and recommended the lv lead replacement.No adverse patient effects were reported.This lv lead remains in service.Additional information was provided that this lv lead potentially exhibited loss of capture (loc), ts indicated that all lv pacing vectors had failed capture testing, and an attempted lead and system revision procedure was unsuccessful due to venous occlusion, followed by an unsuccessful attempt at alternative pacing.Subsequent device interrogation demonstrated no capture in the lv tip-to-ring configuration with high impedance, while successful lv capture was achieved using an lv tip-to-right ventricular (rv) configuration at low output.The device was programmed accordingly, and the patient was reported to be recovering.No adverse patient effects were reported.This lv lead remains in service.
Event or Problem Description
It was reported that this left ventricular (lv) lead recorded high out of range pacing impedance measurements during an in-clinic visit.Technical services (ts) reviewed the device data and recommended the lv lead replacement.No adverse patient effects were reported.This lv lead remains in service.Additional information was provided that this lv lead potentially exhibited loss of capture (loc), ts indicated that all lv pacing vectors had failed capture testing, and an attempted lead and system revision procedure was unsuccessful due to venous occlusion, followed by an unsuccessful attempt at alternative pacing.Subsequent device interrogation demonstrated no capture in the lv tip-to-ring configuration with high impedance, while successful lv capture was achieved using an lv tip-to-right ventricular (rv) configuration at low output.The device was programmed accordingly, and the patient was reported to be recovering.No adverse patient effects were reported.This lv lead remains in service.
Additional Manufacturer Narrative
Follow up report 1 (correction): this report is being submitted to correct the type of reportable event to serious injury report.

• Brand Name: EASYTRAK 2 IS-1
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• 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: 23716789
• Report Number: 2124215-2025-89183
• Device Sequence Number: 8982179
• Product Code: NIK
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2026

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: 10/17/2016
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 304439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 06/22/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/18/2025; 06/23/2026
• Date Device Manufactured: 10/17/2014
• 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: 82 YR
• Patient Sex: Male