FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3041205
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-03006
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- January 14, 2013
- Report Date
- January 15, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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 THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. UPON REMOVAL OF THIS LEAD, THE TIP BECAME SEPARATED FROM THE LEAD BODY AND LODGED IN PULMONARY ARTERY. THE LEAD TIP WILL BE SNARED AND REMOVED BY INTERVENTIONAL CARDIOLOGIST AT A LATER TIME. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143460 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| L| R | 4470| T165| 0175 |