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

Model Number	4542
Medical Device Problem Codes	Defective Device (2588); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this lead was surgically abandoned and replaced due to an unknown product performance issue at this time.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The local area sales representative was contacted for additional information regarding event cause.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this lead was surgically abandoned and replaced due to an unknown product performance issue at this time.No additional adverse patient effects were reported.Additional information was provided that this lead exhibited high capture thresholds.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The local area sales representative was contacted for additional information regarding event cause.At this time, no further information is available.Should additional information become available this report will be updated.

• 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): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23438662
• Report Number: 2124215-2025-78532
• Device Sequence Number: 8689638
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: (01)00802526410901(17)090703
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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): 11/21/2025

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: 07/03/2009
• Device Model Number: 4542
• Device Catalogue Number: 4542
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/21/2025
• Date Device Manufactured: 07/03/2007
• 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: 81 YR
• Patient Sex: Female