MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3 IS-1; IMPLANTABLE LEAD

Model Number	4549
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) and this left ventricular (lv) lead exhibited oversensing of the atrial events in the lv channel.This caused a decrease in the lv pacing percentage and pacing inhibition.Technical services (ts) recommended turning lv sensing off and to bring in the patient to ensure lead measurements were in range.This lv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) and this left ventricular (lv) lead exhibited oversensing of the atrial events in the lv channel.This caused a decrease in the lv pacing percentage and pacing inhibition.Technical services (ts) recommended turning lv sensing off and to bring in the patient to ensure lead measurements were in range.This lv lead remains in service.No adverse patient effects were reported.Additional information was received from the field.The oversensing was caused by the lead position.The patient was not pacer dependent.Lv sensing was turned off and it was confirmed lead measurements were normal.
Additional Manufacturer Narrative
Additional information added to b5.

• Brand Name: EASYTRAK 3 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: 23546604
• Report Number: 2124215-2025-82717
• Device Sequence Number: 9449076
• Product Code: LWP
• UDI-Device Identifier: 00802526420399
• UDI-Public: (01)00802526420399(17)100912
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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
• Report Date (Section B): 11/24/2025

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: 09/12/2010
• Device Model Number: 4549
• Device Catalogue Number: 4549
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 11/24/2025
• Date Device Manufactured: 09/12/2008
• 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: 77 YR
• Patient Sex: Male