FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3210199
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08169
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 16, 2013
- Report Date
- April 16, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD ENDOCARDITIS AND INFECTION WITH FULL BODY SEPSIS. THE PATIENT'S ENTIRE SYSTEM WAS EXPLANTED. THE DEVICE WAS TEMPORARILY USED AS AN EXTERNAL PACEMAKER AND WAS INTERFACED TO A LEAD INSERTED IN THE PATIENT'S JUGULAR VEIN. A NEW SYSTEM WILL IMPLANTED AFTER THE PATIENT RECEIVED ANTIBIOTICS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311302 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization| L | 1273| 4136| 430-02| 438-01| S602| 284-05| 4135| 4456 |