FDA Adverse Event
Injury
Summary report: N
LEAD MODEL UNKNOWN
MDR report key: 2352591
·
Received November 30, 2011
Report
- Report Number
- 1644487-2011-02890
- Event Type
- Injury
- Date Received
- November 30, 2011
- Date of Event
- February 4, 2011
- Report Date
- November 7, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
VAGUS NERVE STIMULATION FOR EPILEPSY: THE NORTE-DAME HOSPITAL EXPERIENCE BY QIABI, M., BOUTHILLIER, A., CARMANT, L., NGUYEN, D.K. CAN. J. NEUROL. SCI. 2011: 38: 902-908.
Description of Event or Problem · 1
IT WAS REPORTED IN AN ARTICLE ENTITLED "VAGUS NERVE STIMULATION FOR EPILEPSY: THE NOTRE-DAME HOSPITAL EXPERIENCE" THAT ONE PATIENT DEVELOPED PERSISTENT LEFT HORNER SYNDROME FOLLOWING VNS IMPLANTATION. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Description of Event or Problem · 1
FOLLOW UP WAS PERFORMED WITH THE AUTHOR OF THE ARTICLE HOWEVER HE WILL NOT BE ABLE TO PROVIDE ANY ADDITIONAL INFORMATION DUE TO CONFIDENTIALITY AGREEMENTS HE SIGNED WHEN GATHERING THE DATA FOR THE ARTICLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL UNKNOWN | LEAD | LYJ | CYBERONICS, INC. | ASKU | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |