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

Model Number	4470
Medical Device Problem Codes	Failure to Capture (1081); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	08/09/2026
Type of Reportable Event	Serious Injury
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 this cardiac resynchronization therapy pacemaker (crt-p) system exhibited loss of capture (loc) and elevated thresholds on the right ventricular (rv) channel.It was noted this crt-p system was recently implanted, and the patient had an atrioventricular (av) node ablation.It was also noted the patient presented to the emergency room (er) due to lightheadedness approximately four days after the implant procedure.Information from the field was received and noted a chest x-ray was performed which confirmed rv lead dislodgement.It was also noted the loc was due to the dislodgement.The patient was admitted to the hospital, and a lead revision procedure was performed.No additional adverse patient effects were reported.This rv lead remains in service.

• 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: 50600227
• Report Number: 2124215-2026-46382
• Device Sequence Number: 13404301
• Product Code: DTB
• UDI-Device Identifier: 00802526264993
• UDI-Public: (01)00802526264993(17)280401
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P960004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: 921626
• 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
• Initial Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 04/01/2026
• 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: 69 YR
• Patient Sex: Unknown