FDA Adverse Event
Other
Summary report: N
PULSE GEN MODEL 102
MDR report key: 833101
·
Received March 23, 2007
Report
- Report Number
- 1644487-2007-00072
- Event Type
- Other
- Date Received
- March 23, 2007
- Date of Event
- September 1, 2006
- Report Date
- November 2, 2006
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS: PNEUMONIA IS A WELL KNOWN COMPLICATION GENERALLY RELATED TO ASPIRATION UPON EXTUBATIONS OF PTS.
Description of Event or Problem · 1
REPORTER INDICATED THAT A PT EXPERIENCED PNEUMONIA FOLLOWING VNS THERAPY EXPLANT. FURTHER F/U WITH THE SURGEON INDICATED THE PNEUMONIA WAS RELATED TO THE SURGICAL PROCEDURE. THE PT WAS HOSPITALIZED FOR 7 DAYS FOLLOWING THE SURGERY, AND THEN RELEASED. THE PNEUMONIA RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | LYJ | CYBERONICS, INC. | 102 | 13476 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization| O| R |