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

Model Number	4473
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Dizziness (2194); Swelling/ Edema (4577)
Date of Event	12/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this pacemaker system triggered a lead safety switch (lss) on the right atrial (ra) lead due to a high out of range pacing impedance measurement.As a result, the right atrial automatic threshold (raat) test was suspended, and minute ventilation (mv) was disabled.Additionally, inappropriate atrial tachy response (atr) episodes were stored due to oversensed noise on the lead.It was found that this lead was fractured.The patient experienced worsening fatigue, lightheadedness, dyspnea, and lower extremity edema.Following the worsening symptoms, the patient's medications were increased.It was noted that this patient is pacemaker dependent and has a history of venous insufficiency.Subsequently, this lead was capped and replaced.No additional adverse patient effects were reported.

• Brand Name: FINELINE II EZ 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: 25334409
• Report Number: 2124215-2026-28942
• Device Sequence Number: 18607041
• Product Code: DTB
• UDI-Device Identifier: 00802526265020
• UDI-Public: (01)00802526265020(17)110303
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: 03/03/2011
• Device Model Number: 4473
• Device Catalogue Number: 4473
• Device Lot Number: 466124
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 07/13/2026
• Date Device Manufactured: 03/03/2009
• 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: Male