FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1202921
·
Received October 17, 2008
Report
- Report Number
- 1644487-2008-02526
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- September 18, 2008
- Report Date
- September 19, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Description of Event or Problem · 1
RPTR INDICATED A VNS THERAPY PT IS BEING REFERRED TO SURGEON FOR EXPLANT OF THE DEVICE. THE REASON FOR THE EXPLANT IS EXACERBATION OF ASTHMA AND PAINFUL STIMULATION. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Other |