MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3 IS-1; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	4549
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the right atrial (ra) lead and left ventricular (lv) lead were explanted and replaced due to non-capture.No additional adverse patient effects were reported.Product return was requested.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding lead return status.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the right atrial (ra) lead and left ventricular (lv) lead were explanted and replaced due to non-capture.No additional adverse patient effects were reported.Product return was requested.Additional information received reported that x-rays confirmed all leads were in the same position prior to lead explant.No pacing system analyzer (psa) testing was noted prior to explant.Additionally, elevated thresholds were observed at multiple checks.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the right atrial (ra) lead and left ventricular (lv) lead were explanted and replaced due to non-capture.No additional adverse patient effects were reported.Product return was requested.Additional information received reported that x-rays confirmed all leads were in the same position prior to lead explant.No pacing system analyzer (psa) testing was noted prior to explant.Additionally, elevated thresholds were observed at multiple checks.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Visual inspection confirmed that the lead was returned in two segments with a total length of approximately 900 millimeters (mm) and severed approximately 294 mm from the terminal end.It was suspected that some segments may be missing.Testing was completed to assess lead electrical performance and insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies (other than damage consistent with explant).Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.

• Brand Name: EASYTRAK 3 IS-1
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 20233551
• Report Number: 2124215-2024-57885
• Device Sequence Number: 12752827
• Product Code: LWP
• UDI-Device Identifier: 00802526420399
• UDI-Public: 00802526420399
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2025

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: 05/18/2012
• Device Model Number: 4549
• Device Catalogue Number: 4549
• Device Lot Number: 173498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 09/16/2024; 02/06/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 09/24/2024; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2010
• 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: 76 YR
• Patient Sex: Male