FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL UNKNOWN
MDR report key: 1521054
·
Received November 3, 2009
Report
- Report Number
- 1644487-2009-02449
- 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 HIGH LEAD IMPEDANCE LED TO MEDICAL INTERVENTION BEING TAKEN DUE TO A PIN RE-INSERTION ISSUE ON A VNS PATIENT. 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 UNKNOWN | NONE | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |