FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 1583451
·
Received January 19, 2010
Report
- Report Number
- 1644487-2010-00138
- Event Type
- Injury
- Date Received
- January 19, 2010
- Date of Event
- January 16, 2003
- Report Date
- December 21, 2009
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ARTICLE CITATION - MURPHY, JEROME V., RICHARD TORKELSON, IRENE DOWLER, AND STEPHEN SIMON. "VAGAL NERVE STIMULATION IN REFRACTORY EPILEPSY". ARCH PEDIATR ADOLESC MED 157 (2003): 560-64. PRINT.
Description of Event or Problem · 1
IT WAS REPORTED IN A SCIENTIFIC ARTICLE THAT A VNS PT DEVELOPED ABSCESS AROUND THE GENERATOR REQUIRING REMOVAL OF THE DEVICE, ANTIBIOTIC THERAPY, AND RE-IMPLANTATION. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL UNK | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |