FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1061986
·
Received June 13, 2008
Report
- Report Number
- 1644487-2008-01369
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Date of Event
- May 15, 2008
- Report Date
- May 16, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO MFR THAT THE VNS DEVICE WAS NOT RESPONDING WHEN ATTEMPTING TO COMMUNICATE WITH THE PT'S DEVICE. THE PT HAD THE GENERATOR EXPLANTED DUE TO AN UNRELATED EXTRUSION AND POSSIBLE INFECTION EVENT, WHICH HAS BEEN REPORTED IN MEDWATCH # 1644487-2008-01367. ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE TREATING PHYSICIAN ARE UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 6181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |