FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3213011
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09138
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- June 1, 2013
- Report Date
- June 5, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A FEW WEEKS POST IMPLANT, THIS RIGHT ATRIAL LEAD WAS CONFIRMED DISLODGED VIA AN X-RAY IMAGE. THE PHYSICIAN ELECTED TO SURGICALLY INTERVENE AND REPOSITION THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND TO DATE, THE LEAD REMAINS IMPLANTED AND IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312819 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4480 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |