MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; PERMANENT PACEMAKER ELECTRODE

Model Number	4458
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this right ventricular (rv) lead had fracture.This lead was surgically abandoned.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead experienced fracture, due to this, noise, oversensing and high pacing impedance issues were observed.This lead was surgically abandoned.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
**udi related data quality updates only** this report is being filed as a correction in response to an fda request for the complete the unique identifier (udi) #.
Event or Problem Description
It was reported that this right ventricular (rv) lead experienced fracture, due to this, noise, oversensing and high pacing impedance issues were observed.This lead was surgically abandoned.No additional adverse patient effects were reported.

• Brand Name: FINELINE II STEROX
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• 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: 18342747
• Report Number: 2124215-2023-71531
• Device Sequence Number: 15555402
• Product Code: DTB
• UDI-Device Identifier: 00802526060953
• UDI-Public: (01)00802526060953(17)030316(21)200856
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• 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,Followup
• Report Date (Section B): 08/18/2024

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: 03/16/2003
• Device Model Number: 4458
• Device Catalogue Number: 4458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 12/22/2023; 07/25/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/11/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2001
• 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 Sex: Female