FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 2972576
·
Received February 21, 2013
Report
- Report Number
- 1644487-2013-00473
- Event Type
- Injury
- Date Received
- February 21, 2013
- Date of Event
- February 1, 2012
- Report Date
- January 28, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(4) 2013 CLINIC NOTES WERE RECEIVED WHICH INDICATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012 AFTER HE PRESENTED WITH STATUS EPILEPTICUS AT AN OUTSIDE EMERGENCY ROOM. GOOD FAITH ATTEMPTS WERE MADE FOR FURTHER INFORMATION FROM THE PHYSICIAN BUT NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75413 | PULSE GEN MODEL 103 | GENERATOR | LYJ | CYBERONICS INC | 103 | 200774 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Hospitalization |