FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1031129
·
Received April 18, 2008
Report
- Report Number
- 1644487-2008-00952
- Event Type
- Injury
- Date Received
- April 18, 2008
- Date of Event
- March 27, 2008
- Report Date
- March 27, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SEE SCANNED PAGE.
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT THEY HAD A PT WITH THE VNS IN THEIR HOSPITAL ADMITTED BECAUSE THEY WERE HAVING SEIZURES. IT IS UNK IF THE SEIZURES THE PT WAS HAVING WERE ABOVE THEIR PRE VNS SEIZURE RATE. GOOD FAITH ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL DETAILS SURROUNDING THE EVENT AND NO FURTHER INFORMATION HAS BEEN ATTAINED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 7380 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |