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

Model Number	4518
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted due to an unknown product performance issue.This lead was not replaced because the patient received new non-boston scientific leadless pacemaker.This lv lead was returned to boston scientific but further analysis has not been performed.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted due to an unknown product performance issue.This lead was not replaced because the patient received new non-boston scientific leadless pacemaker.This lv lead was returned to boston scientific but further analysis has not been performed.No additional adverse patient effects were reported.Additional information was received, this lv lead was explanted due to infection.This lv lead was returned to boston scientific but further analysis has not been performed.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted due to an unknown product performance issue.This lead was not replaced because the patient received new non-boston scientific leadless pacemaker.This lv lead was returned to boston scientific but further analysis has not been performed.No additional adverse patient effects were reported.Additional information was received, this lv lead was explanted due to infection.This lv lead was returned to boston scientific but further analysis has not been performed.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Follow up report 2 (correction): adverse event/product problem b1 and devices codes h6 fields were updated.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Infection is a known medical risk when the skin barrier is breached.Analysis of the returned product is not able to provide relevant information for infection-related allegations.
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted due to an unknown product performance issue.This lead was not replaced because the patient received new non-boston scientific leadless pacemaker.This lv lead was returned to boston scientific but further analysis has not been performed.No additional adverse patient effects were reported.Additional information was received, this lv lead was explanted due to infection.This lv lead was returned to boston scientific but further analysis has not been performed.No additional adverse patient effects were reported.

• Brand Name: EASYTRAK 2
• 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: 20635020
• Report Number: 2124215-2024-70199
• Device Sequence Number: 7385646
• Product Code: NIK
• UDI-Device Identifier: 00802526417672
• UDI-Public: 00802526417672
• 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: 2006
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/27/2024

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: 10/13/2007
• Device Model Number: 4518
• Device Catalogue Number: 4518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 11/22/2024; 11/25/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 11/13/2024; 11/22/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2005
• 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: 80 YR
• Patient Sex: Female