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

Model Number	4479
Medical Device Problem Codes	Failure to Capture (1081); Defective Device (2588); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right atrial (ra) lead exhibited a gradual rise in capture threshold and it was suspected that the lead had been damaged during an unrelated procedure.The lead was sensing appropriately and had withing range impedances.The lead was confirmed to be exhibiting failure to capture.This lead was surgically abandoned and successfully replaced.No additional adverse patient effects were reported.

• Brand Name: FINELINE II 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: 23430129
• Report Number: 2124215-2025-78256
• Device Sequence Number: 9863709
• Product Code: DTB
• UDI-Device Identifier: 00802526061936
• UDI-Public: (01)00802526061936(17)130223
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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: 02/23/2013
• Device Model Number: 4479
• Device Catalogue Number: 4479
• Device Lot Number: 464649
• 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: 10/08/2025
• Initial Report FDA Received Date: 10/30/2025
• Date Device Manufactured: 02/23/2011
• 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: 84 YR
• Patient Sex: Male