MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II Sterox; Implantable Lead

Model Number	4457
Medical Device Problem Codes	Over-Sensing (1438); Extracardiac stimulation (1463)
Health Effect - Clinical Code	Device Overstimulation of Tissue (1991)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with this right ventricular (rv) lead experienced pocket stimulation.The device experienced minute ventilation signal oversensing.The lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: FINELINE II Sterox
• Common Device Name: Implantable Lead
• 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; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25493752
• Report Number: 2124215-2026-31678
• Device Sequence Number: 9965542
• Product Code: DTB
• UDI-Device Identifier: 00802526060915
• UDI-Public: (01)00802526060915(17)170410
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 04/10/2017
• Device Model Number: 4457
• Device Catalogue Number: 4457
• Device Lot Number: 798517
• 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: 05/19/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 04/10/2015
• 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: 65 YR
• Patient Sex: Male