FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1512746
·
Received October 9, 2009
Report
- Report Number
- 1644487-2009-02268
- Event Type
- Injury
- Date Received
- October 9, 2009
- Date of Event
- January 1, 2009
- Report Date
- September 10, 2009
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS COMPLAINING OF SHORTNESS OF BREATH AND AT TIMES SHE WOULD TURN BLUE. PT STATED THE EVENT OCCURRED WITH STIMULATION. PHYSICIAN DID NOT VISUALIZE EVENT WHEN PT WAS SEEN IN THE OFFICE. PT'S SETTINGS HAD BEEN INCREASED IN 2009, FROM 1MA TO 1.25 MA OUTPUT. ATTEMPTS FOR 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 | 200812 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other |