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

Model Number	4473
Medical Device Problem Codes	High impedance (1291); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort was performed to obtain additional information.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 ventricular (rv) lead was capped and surgically abandoned due to a product performance issue.A new device was implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
A good faith effort was performed to obtain additional information.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 ventricular (rv) lead was capped and surgically abandoned due to a product performance issue.A new device was implanted.No additional adverse patient effects were reported.Additional information from the field indicates this rv lead exhibited high out of range impedance measurements.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: 24133314
• Report Number: 2124215-2026-03859
• Device Sequence Number: 10344343
• Product Code: DTB
• UDI-Device Identifier: 00802526265020
• UDI-Public: (01)00802526265020(17)141120
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 02/02/2026

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: 11/20/2014
• Device Model Number: 4473
• Device Catalogue Number: 4473
• Device Lot Number: 484370
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/02/2026
• Date Device Manufactured: 11/20/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female