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

Model Number	4469
Medical Device Problem Codes	Low impedance (2285); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this patient recently had an open-heart surgery and this right atrial (ra) impedance measurements were measuring around 400 ohms.The physician wanted to find out of this system was magnetic resonance imaging (mri) compatible.There was no evidence of fractured lead or compromised pulse generator-lead system integrity.Technical services (ts) reviewed and stated that this ra lead exhibited high capture thresholds, measuring at 4.5v.This device was programmed at vddr.Ts stated that this system is not mri compatible as the ra lead was dislodged.This lead remains in service.No 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; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50601353
• Report Number: 2124215-2026-45919
• Device Sequence Number: 10710624
• Product Code: DTB
• UDI-Device Identifier: 00802526265143
• UDI-Public: (01)00802526265143(17)260214
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: 02/14/2026
• Device Model Number: 4469
• Device Catalogue Number: 4469
• Device Lot Number: 633454
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 02/14/2024
• 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: Female