FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1269756
·
Received December 18, 2008
Report
- Report Number
- 1644487-2008-03068
- Event Type
- Injury
- Date Received
- December 18, 2008
- Date of Event
- January 1, 2006
- Report Date
- November 21, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PATIENTS REPORTED THAT SHE DEVELOPED SLEEP APNEA AFTER SHE WAS IMPLANTED WITH THE VNS DEVICE. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | MUZ | CYBERONICS, INC. | 102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Life Threatening |