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

Model Number	4479
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Failure to Read Input Signal (1581); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system with this right atrial (ra) and right ventricular (rv) lead exhibited within range high pacing impedance increasing gradually over a period of three months.Additionally, rv lead noted to have bouncy threshold readings between 0.8 volts and 3 volts.Presenting electrocardiogram showed ra had poor p wave morphology and farfield oversensing.There were no changes made to the lead.This system remains in service and no adverse patient effects were reported.
Event or Problem Description
It was reported that the system with this right atrial (ra) and right ventricular (rv) lead exhibited within range low pacing impedance decreasing gradually over a period of three months.Additionally, rv lead noted to have bouncy threshold readings between 0.8 volts and 3 volts.Presenting electrocardiogram showed ra had poor p wave morphology and farfield oversensing.There were no changes made to the lead.This system remains in service and no adverse patient effects were reported.
Additional Manufacturer Narrative
Field b5 and h6 has been corrected.

• 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: 22491775
• Report Number: 2124215-2025-46682
• Device Sequence Number: 12790378
• Product Code: DTB
• UDI-Device Identifier: 00802526061936
• UDI-Public: (01)00802526061936(17)230512
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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: 05/12/2023
• Device Model Number: 4479
• Device Catalogue Number: 4479
• Device Lot Number: 484133
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/04/2025
• Date Device Manufactured: 05/12/2021
• 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: 82 YR
• Patient Sex: Male