FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102R
MDR report key: 3172897
·
Received June 17, 2013
Report
- Report Number
- 1644487-2013-01801
- Event Type
- Injury
- Date Received
- June 17, 2013
- Report Date
- May 20, 2013
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
CLINIC NOTES WERE RECEIVED FOR REVIEW REPORTING THAT A VNS PATIENT WAS IN STATUS A COUPLE OF YEARS AGO FOR 7 DAYS. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS ABOUT THE REPORTED EVENT.
Description of Event or Problem · 1
ATTEMPTS FOR ADDITONAL INFORMATION HAVE BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273367 | PULSE GEN MODEL 102R | PULSE GEN MODEL 102R | LYJ | CYBERONICS, INC. | 102R | 016318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |