FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1022734
·
Received March 27, 2008
Report
- Report Number
- 1644487-2008-00804
- Event Type
- Malfunction
- Date Received
- March 27, 2008
- Date of Event
- January 1, 2002
- Report Date
- March 10, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED A PT'S VNS WAS EXPLANTED DUE TO NEVER HAVING EFFICACY WITH THE VNS DESPITE MULTIPLE PROGRAMMING CHANGES. FURTHER ATTEMPTS FOR ADD'L INFO FROM THE ATTENDING NEUROLOGIST HAVE BEEN UNSUCCESSFUL TO DATE. THE EXPLANTED LEAD AND GENERATOR HAVE BEEN REQUESTED, BUT HAVE NOT BEEN RETURNED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 125411 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |