FINELINE II EZ STEROX
Report
- Report Number
- 2124215-2025-79416
- Event Type
- Injury
- Date Received
- November 4, 2025
- Date of Event
- October 14, 2025
- Report Date
- November 10, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DTB
- UDI-DI
- 00802526264993
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED A SUDDEN HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT. PACING IMPEDANCE MEASUREMENTS HAD PREVIOUSLY BEEN STABLE WITHIN RANGE. SUBSEQUENTLY, THIS RA LEAD WAS SURGICALLY ABANDONED. ANOTHER RA LEAD WAS IMPLANTED TO COMPLETE THIS PROCEDURE. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE PROVIDED THIS LEAD WAS SURGICALLY ABANDONED DUE TO A FRACTURE. THIS FRACTURE RESULTED IN INHIBITION OF PACING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED A SUDDEN HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT. PACING IMPEDANCE MEASUREMENTS HAD PREVIOUSLY BEEN STABLE WITHIN RANGE. SUBSEQUENTLY, THIS RA LEAD WAS SURGICALLY ABANDONED. ANOTHER RA LEAD WAS IMPLANTED TO COMPLETE THIS PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2738639 | FINELINE II EZ STEROX | IMPLANTABLE LEAD | DTB | BOSTON SCIENTIFIC CORPORATION | 4470 | 478186 | 00802526264993 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Female | Required Intervention| H |