MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II EZ Sterox; Permanent Pacemaker Electrode

Model Number	4473
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right atrial (ra) lead exhibited high out of range pacing impedance measurements.The rep confirmed the impedances spiked out of range about three times over the past year and then returned to normal.Technical services (ts) recommended isometrics to test the lead integrity.There was noise present that was not oversensed.This lead has been recommended for replacement.This ra lead remains in service.No adverse patient effects were reported.

• Brand Name: FINELINE II EZ 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50899034
• Report Number: 2124215-2026-51220
• Device Sequence Number: 14959079
• Product Code: DTB
• UDI-Device Identifier: 00802526265020
• UDI-Public: (01)00802526265020(17)090705
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: 07/05/2009
• Device Model Number: 4473
• Device Catalogue Number: 4473
• 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: 08/27/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/25/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 07/05/2007
• 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
• Patient Sex: Female