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

Model Number	4479
Medical Device Problem Codes	Failure to Capture (1081); Failure to Read Input Signal (1581); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the right atrial automatic threshold (raat) tests on this right atrial (ra) lead were noted to be suspended.Technical services (ts) was consulted, upon review of the available information suspected loss of capture (loc), low intrinsic amplitude and high capture thresholds were observed.This right atrial (ra) lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that the right atrial automatic threshold (raat) tests on this right atrial (ra) lead were noted to be suspended.Technical services (ts) was consulted, upon review of the available information suspected loss of capture (loc), low intrinsic amplitude and high capture thresholds were observed.This right atrial (ra) lead remains in service.No adverse patient effects were reported.Additional information was received stating that the patient underwent a procedure to replace the associated pacemaker.

• 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: 24989682
• Report Number: 2124215-2026-22452
• Device Sequence Number: 21458947
• Product Code: DTB
• UDI-Device Identifier: 00802526061936
• UDI-Public: (01)00802526061936(17)100902
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2026

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: 09/02/2010
• Device Model Number: 4479
• Device Catalogue Number: 4479
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 04/06/2026; 07/08/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 04/28/2026; 07/09/2026
• Date Device Manufactured: 09/02/2008
• 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 Sex: Male