FDA Adverse Event
Injury
Summary report: N
FINELINE II STEROX
MDR report key: 3211130
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-09131
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 29, 2013
- Report Date
- March 8, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DTB
- UDI-DI
- 00802526061936
- PMA / PMN Number
- P960004/S014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL INFORMATION WAS RECEIVED OVER ONE YEAR AFTER THE INITIAL OBSERVATIONS WERE REPORTED CONFIRMING THIS LEAD WAS STILL EXHIBITING HIGH, OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WHICH HAD EXCEEDED 2500 OHMS OVER THE PAST YEAR.
Additional Manufacturer Narrative · 1
A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER. THE PATIENT WILL BE BROUGHT BACK IN THREE MONTHS TO RE-EVALUATE THE LEAD. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS EXHIBITING INCREASED IMPEDANCE MEASUREMENTS FROM 500-2100 OHMS AND RISING THRESHOLD MEASUREMENTS. THE CALLER SUSPECTS A POSSIBLE LEAD FRACTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311813 | FINELINE II STEROX | IMPLANTABLE LEAD | DTB | BOSTON SCIENTIFIC CORPORATION | 4479 | 451114 | 00802526061936 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Male | Hospitalization| R | 4456| 4479| S606| S606| 4456| 4479 |