FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 2093977
·
Received May 16, 2011
Report
- Report Number
- 1644487-2011-01085
- Event Type
- Injury
- Date Received
- May 16, 2011
- Date of Event
- October 7, 2009
- Report Date
- April 18, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ARTICLE CITATION: CERSOSIMO, RICADO O., MARCELO BARTALUCHI, CECILIA DE LOS SANTOS,L IRENE BONVEHI, AND HUGO POMATA. "VAGUS NERVE STIMULATION: EFFECTIVENESS AND TOLERABILITY IN PTS WITH EPILEPTIC ENCEPHALOPATHIES." CHILDS NERV SYST 27 (2011): 787-92.
Description of Event or Problem · 1
IT WAS REPORTED IN A SCIENTIFIC ARTICLE THAT A VNS PT EXPERIENCED AN INFECTIOUS COMPLICATION THAT HAS NOT RESOLVED YET, LEADING TO THE DEVICE BEING CHANGED. 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 | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |