MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; IMPLANTABLE LEAD

Model Number	4479
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 right atrial (ra) lead was explanted due to an unknown product performance anomaly.No additional adverse patient effects were reported.This ra lead has not been returned to boston scientific.
Event or Problem Description
It was reported that this right atrial (ra) lead was explanted due to a lead product performance anomaly.No additional adverse patient effects were reported.This ra lead has not been returned to boston scientific.Additional information indicated that this lead exhibited noise oversensing and high within range pacing impedance measurements.No additional adverse patient effects were reported.This ra lead has not been returned to boston scientific.
Additional Manufacturer Narrative
This report is being submitted to update section b5 and h6 codes.At this time, no further information is available.Should additional information become available this report will be updated.
Additional Manufacturer Narrative
This report is being submitted to update section b5.This report is being submitted to update section b5 and h6 codes.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 right atrial (ra) lead was explanted due to a lead product performance anomaly.No additional adverse patient effects were reported.This ra lead has not been returned to boston scientific.Additional information indicated that this lead exhibited noise oversensing and high within range pacing impedance measurements.No additional adverse patient effects were reported.This ra lead has not been returned to boston scientific.Additional information indicated that this ra lead is not expected to be returned since it was disposed.No additional adverse patient effects were reported.

• 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; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23251389
• Report Number: 2124215-2025-71588
• Device Sequence Number: 18684130
• Product Code: DTB
• UDI-Device Identifier: 00802526061936
• UDI-Public: (01)00802526061936(17)161007
• Combination Product (Y/N): Y
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2025

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: 10/07/2016
• Device Model Number: 4479
• Device Catalogue Number: 4479
• Device Lot Number: 477839
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 12/02/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/20/2025; 12/09/2025
• Date Device Manufactured: 10/07/2014
• 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: 75 YR
• Patient Sex: Female