FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 2030805
·
Received March 4, 2011
Report
- Report Number
- 1644487-2011-00434
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Date of Event
- February 3, 2011
- Report Date
- February 3, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S VNS GENERATOR HAD INDICATED "NOT DELIVERING CURRENT" HOWEVER, THE IMPEDANCE AND BATTERY WERE OK AS PER THE PHYSICIAN. THE PT AND PRODUCT INFO WERE NOT PROVIDED AND ATTEMPTS FOR FURTHER INFO 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 |