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

Model Number	4479
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and procedure information.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that the pacemaker device that was implanted in him since 2003.He stated his original pacemaker and leads of boston scientific was implanted in (b)(6) 2003.He said no one told him the leads should be replaced every 5 to 7 years.Up until 3 years ago, he was having the same leads and was not aware that they should have been changed a long time ago.He said one doctor told him they should only last 5 to 7 years.He said he saw a doctor in 2022 and that doctor only changed the pacemaker and the battery.He said after the replacement he was still getting inappropriate shocks and incorrect transmission.He said in (b)(6) of 2024 in one day, he got 12 inappropriate shocks.Then he went to another doctor with his concerns and in (b)(6) of 2024, the entire system has been replaced.He said when the doctor was changing the leads they were rotten, deteriorated and crumbled.Now he does not have any problems with the new system.

• 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: 21905937
• Report Number: 2124215-2025-26327
• Device Sequence Number: 8821450
• Product Code: DTB
• UDI-Device Identifier: 00802526061936
• UDI-Public: (01)00802526061936(17)041007
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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: 10/07/2004
• Device Model Number: 4479
• Device Catalogue Number: 4479
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/24/2025
• Date Device Manufactured: 10/07/2002
• 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 Age: 60 YR
• Patient Sex: Male