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

Model Number	4459
Medical Device Problem Codes	Signal Artifact/Noise (1036); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited noise and impedance.Subsequently this lead was surgically abandoned, and a new lead was successfully implanted.No additional patient adverse 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 exhibited noise and impedance.Subsequently this lead was surgically abandoned, and a new lead was successfully implanted.No additional patient adverse 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: 18173100
• Report Number: 2124215-2023-65411
• Device Sequence Number: 18041827
• Product Code: DTB
• UDI-Device Identifier: 00802526061004
• UDI-Public: (01)00802526061004(17)040712(21)310705
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 07/12/2004
• Device Model Number: 4459
• Device Catalogue Number: 4459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 08/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2002
• 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: Male