MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II EZ Sterox; Implantable lead

Model Number	4470
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted due to unknown reasons.Additional information was requested but unable to be obtained at this time.No additional adverse patient effects were reported.This lv lead has not been returned for analysis.Additional information was received and it was reported that this lead that was explanted was the right ventricular (rv) lead.This lead was explanted due to physician preference, and no anomalies were noted with the lead.No additional adverse patient effects were reported.This rv lead has not been returned for analysis.
Additional Manufacturer Narrative
This report is being submitted to update the information in section b5.This device was explanted and was not returned.As such, physical analysis has not been conducted in our laboratory.Based on the available information, and in the absence of a product return, the investigation conclusion code no problem detected was selected.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: FINELINE II EZ 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; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50600407
• Report Number: 2124215-2026-46220
• Device Sequence Number: 10732120
• Product Code: DTB
• UDI-Device Identifier: 00802526264993
• UDI-Public: (01)00802526264993(17)280416
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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 Model Number: 4470
• Device Catalogue Number: 4470
• Device Lot Number: 921887
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 04/16/2026
• 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: 79 YR
• Patient Sex: Unknown