FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2801818
·
Received October 23, 2012
Report
- Report Number
- 2124215-2012-14184
- Event Type
- Injury
- Date Received
- October 23, 2012
- Date of Event
- August 31, 2012
- Report Date
- August 31, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 THERE WAS A PERFORATION OF THE LUNG DUE TO A NEEDLE STICK WHILE ATTEMPTING TO GAIN ACCESS TO A VEIN FOR THIS RIGHT VENTRICLE LEAD. THE LEAD WAS SUCCESSFULLY IMPLANTED, HOWEVER THE PATIENT STARTED HAVING SYMPTOMS SHORTLY AFTER. A CHEST TUBE WAS PLACED TO REMEDY THE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |