FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 1520360
·
Received November 3, 2009
Report
- Report Number
- 1644487-2009-02457
- Event Type
- Injury
- 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
- Adverse Event
- 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 PNEUMOGASTRIGUE 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 VNS PT EXPERIENCED PAIN AT THE GENERATOR SITE. FURTHERMORE, THE SURGEON REPOSITIONED THE GENERATOR TO PRECLUDE THE PAIN BUT EVEN AFTER REPOSITIONING OF THE GENERATOR THE PAIN PERSISTED. AT THE MOMENT, GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL UNK | NONE | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |