FDA Adverse Event
Other
Summary report: N
PULSE GEN MODEL 102
MDR report key: 793647
·
Received December 7, 2006
Report
- Report Number
- 1644487-2006-00447
- Event Type
- Other
- Date Received
- December 7, 2006
- Date of Event
- August 25, 2006
- Report Date
- September 22, 2006
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- p970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
H.6. PNEUMONIA IS A WELL KNOWN COMPLICATION GENERALLY RELATED TO ASPIRATION UPON EXTUBATION OF PATIENTS.
Description of Event or Problem · 1
REPORTER INDICATED THAT A PATIENT EXPERIENCED PNEUMONIA FOLLOWING VNS THERAPY IMPLANTATION. FURTHER FOLLOW UP WITH THE TREATING PHYSICIAN INDICATED THE PNEUMONIA WAS RELATED TO THE SURGICAL PROCEDURE. THE PNEUMONIA RESOLVED PRIOR TO THE PATIENT'S NEXT OFFICE VISIT APPROXIMATELY ONE MONTH LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | LYJ | CYBERONICS, INC. | 102 | 14007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 MO | Other |