MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II EZ STEROX; PERMANENT PACEMAKER ELECTRODE

Model Number	4471
Medical Device Problem Codes	High impedance (1291); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and resolution.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 during a device check of this pacemaker system prior to magnetic resonance imaging (mri) scan, high out-of-range pace impedance measurements greater than 2,000 ohms on the right ventricular (rv) lead.Review pace impedance trends showed a gradual rise in measurements since (b)(6) 2025 that was suspected to attributed to a physiologic cause.It was noted that the clinic was monitoring the rv lead, with plans for lead revision at the next routine battery replacement.It was confirmed that the non-conditional mri scan was completed with appropriate orders.This rv lead remains in service.No adverse patient effects or interventions were reported at this time.

• Brand Name: FINELINE II EZ STEROX
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• 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: 24656839
• Report Number: 2124215-2026-15678
• Device Sequence Number: 14710465
• Product Code: DTB
• UDI-Device Identifier: 00802526265006
• UDI-Public: (01)00802526265006(17)210327
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2026

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: 03/27/2021
• Device Model Number: 4471
• Device Catalogue Number: 4471
• Device Lot Number: 562813
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/21/2026
• Supplement Report FDA Received Date: 05/09/2026
• Date Device Manufactured: 03/27/2019
• 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: 76 YR
• Patient Sex: Male