FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2173271
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10491
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- June 13, 2011
- Report Date
- June 13, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 THIS RIGHT ATRIAL (RA) HAD DISLODGED. A LEAD REVISION PROCEDURE WAS PERFORMED WHERE THIS LEAD WAS SURGICALLY ABANDONED, AND A NEW RA LEAD WAS IMPLANTED. 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 | 4470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| L| R | 4518| 0185| N118| 4470 |