FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1061629
·
Received June 17, 2008
Report
- Report Number
- 1644487-2008-01397
- Event Type
- Malfunction
- Date Received
- June 17, 2008
- Date of Event
- May 27, 2008
- Report Date
- May 23, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED A VNS PT WAS EXPLANTED DUE TO LACK OF EFFICACY. THE EXPLANTED VNS GENERATOR AND LEAD WERE DISCARDED BY THE HOSP. MANUFACTURER PROGRAMMING HISTORY SHOWS THE PT'S VNS WAS DISABLED ON (B) (6) 2007 AND THAT VNS DIAGNOSTICS TESTS PERFORMED THAT DAY WERE NORMAL. NO OTHER PROGRAMMING HISTORY IS AVAILABLE. ATTEMPTS TO THE REPORTER FOR ADDITIONAL INFO ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 014628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |