FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL UNKNOWN
MDR report key: 1521032
·
Received November 3, 2009
Report
- Report Number
- 1644487-2009-02451
- Event Type
- Malfunction
- Date Received
- November 3, 2009
- Date of Event
- January 1, 2008
- Report Date
- October 5, 2009
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ARTICLE CITATION: TURAK, BARIS, AND FRANCOIS X. ROUX. "STIMULATION CHRONIQUE THERAPEUTIQUE DU NERF PNEUMOGASTRIQUE POUR L'EPILEPSIE: ASPECTS CHIRURGICAUX." EPILEPSIES 20 (2008): 18-31.
Description of Event or Problem · 1
IT WAS REPORTED IN A SCIENTIFIC ARTICLE THAT A LEAD FRACTURE WAS FOUND ON A VNS PATIENT. AT THE MOMENT, THE ROOT CAUSE OF THE FRACTURE IS UNKNOWN. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL UNKNOWN | NONE | LYJ | CYBERONICS INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |