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

Model Number	4480
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Codes	Scar Tissue (2060); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right atrial (ra) lead was having a high capture threshold.This lead was surgically abandoned.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right atrial (ra) lead was having a high capture threshold.This lead was surgically abandoned.No additional adverse patient effects were reported.Additional information received indicates that the physician suspected of a muscle area that was maybe compromised by an injury (heart attack or scar).No patient harm 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: 21110625
• Report Number: 2124215-2025-00436
• Device Sequence Number: 12951967
• Product Code: DTB
• UDI-Device Identifier: 00802526061974
• UDI-Public: 00802526061974
• Combination Product (Y/N): Y
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 01/30/2025

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: 07/16/2017
• Device Model Number: 4480
• Device Catalogue Number: 4480
• Device Lot Number: 654375
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/30/2025
• Date Device Manufactured: 07/16/2015
• 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: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female