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

Model Number	4469
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right atrial (ra) lead exhibited noise, impedance above 3000 ohms, and inappropriate pacing inhibition.The lead was surgically abandoned and a new product was implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was requested.This investigation will be updated should further information be provided.

• 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50057152
• Report Number: 2124215-2026-40329
• Device Sequence Number: 10731021
• Product Code: DTB
• UDI-Device Identifier: 00802526265143
• UDI-Public: (01)00802526265143(17)120723
• Combination Product (Y/N): Y
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: 07/23/2012
• Device Model Number: 4469
• Device Catalogue Number: 4469
• Device Lot Number: 533919
• 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: 07/01/2026
• Initial Report FDA Received Date: 07/28/2026
• Date Device Manufactured: 07/23/2010
• 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: 87 YR
• Patient Sex: Male