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

Model Number	4480
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that the pacemaker system with this right atrial (ra) lead exhibited many inappropriate atrial tachy response (atr) episodes.Technical services (ts) advised inappropriate atr episodes were stored due to oversensing of noise.In addition, ts provided there had been an alert of ra out of range pacing impedance measurements.Additional information from the field representative provided pacing impedance measurements were both high and low out of range.Ts suggested troubleshooting options.The patient has been scheduled for a revision procedure.This ra lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the pacemaker system with this right atrial (ra) lead exhibited many inappropriate atrial tachy response (atr) episodes.Technical services (ts) advised inappropriate atr episodes were stored due to oversensing of noise.In addition, ts provided there had been an alert of ra out of range pacing impedance measurements.Additional information from the field representative provided pacing impedance measurements were both high and low out of range.Ts suggested troubleshooting options.The patient has been scheduled for a revision procedure.Additional information provided this ra lead was surgically abandoned.The field representative reported this ra lead was fractured.Another lead was implanted to complete this procedure.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• 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): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 22509988
• Report Number: 2124215-2025-47278
• Device Sequence Number: 8736764
• Product Code: DTB
• UDI-Device Identifier: 00802526061974
• UDI-Public: (01)00802526061974(17)050930
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: 09/30/2005
• Device Model Number: 4480
• Device Catalogue Number: 4480
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 07/28/2025
• Date Device Manufactured: 09/30/2003
• 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: 67 YR
• Patient Sex: Male