FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 3073132
·
Received April 23, 2013
Report
- Report Number
- 1644487-2013-01127
- Event Type
- Injury
- Date Received
- April 23, 2013
- Date of Event
- July 1, 2011
- Report Date
- March 27, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED IN CLINIC NOTES THAT THE STAFF FELT THAT THE PATIENT WAS HAVING A FEW MORE SEIZURES. THE PHYSICIAN DECREASED THE OFF TIME. NO FURTHER INFORMATION WAS NOTED. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173456 | PULSE GEN MODEL 102 | GENERATOR | LYJ | CYBERONICS INC | 102 | 017152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |