FDA Adverse Event
Injury
Summary report: N
FINELINE II STEROX
MDR report key: 8809885
·
Received July 20, 2019
Report
- Report Number
- 2124215-2019-13732
- Event Type
- Injury
- Date Received
- July 20, 2019
- Date of Event
- April 17, 2019
- Report Date
- July 20, 2019
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DTB
- PMA / PMN Number
- P960004/S014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS LEAD WAS LOCATED INTO SUPERIOR VENA CAVA. IT WAS STUCK AND WAS NOT ABLE TO PULLED OUT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED IF THE LEAD WAS CAPPED IT WILL NOT GET MAGNETIC RESONANCE IMAGING (MRI). SINCE THE LEAD WAS STUCK, IT SHOULD NOT BE MOVED. THIS LEAD HAD A REVISION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 603634 | FINELINE II STEROX | PERMANENT PACEMAKER ELECTRODE | DTB | BOSTON SCIENTIFIC CORPORATION | 4456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |