FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL UNKNOWN
MDR report key: 1102483
·
Received August 8, 2008
Report
- Report Number
- 1644487-2008-01828
- Event Type
- Injury
- Date Received
- August 8, 2008
- Date of Event
- January 1, 2001
- Report Date
- July 8, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DARDIS, R., SELWAY, R., KOUTROMANIDIS, M., POLKEY, C.E., "VAGAL NERVE STIMULATORS AND ANAESTHESIA:2." ANAESTHESIA; 2001; 56: 1203-1216.
Description of Event or Problem · 1
IT WAS REPORTED IN AN ARTICLE REVIEWED BY MANUFACTURER THAT THE VNS PATIENT EXPERIENCED PNEUMONIA AFTER DEVICE ACTIVATION. THE LITERATURE STATED THAT "THIS ASSOCIATION MAY NOT BE COINCIDENTAL AND COULD RELATE TO SUBTLE ALTERATIONS IN AIRWAY PHYSIOLOGY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL UNKNOWN | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |