FDA Adverse Event
Malfunction
Summary report: N
NONE
MDR report key: 1022076
·
Received March 28, 2008
Report
- Report Number
- 1644487-2008-00816
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- February 7, 2008
- Report Date
- February 28, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO ANOMALIES IDENTIFIED.
Description of Event or Problem · 1
REPORTER INDICATED THAT COMMUNICATION COULD NOT BE ESTABLISHED WITH THE PT'S GENERATOR AT THREE SEPARATE OFFICE VISITS. TROUBLESHOOTING DID NOT RESOLVE THE EVENT, AND IT WAS REPORTED THAT THE PROGRAMMING SYSTEM COULD BE USED TO COMMUNICATION WITH OTHER PT'S GENERATORS. IT WAS REPORTED THAT THE PT IS HEAVY, ALTHOUGH IT WAS UNK IF THAT WAS A CONTRIBUTING FACTOR. IT WAS REPORTED THAT THE PT IS NON-VERBAL SO IT COULD NOT BE DETERMINED IF SHE WAS ABLE TO PERCEIVE STIMULATION. A GENERATOR RESET WAS PERFORMED, BUT COMMUNICATION STILL COULD NOT BE ESTABLISHED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | LYJ | CYBERONICS, INC. | 101 | 7577 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |