FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 2881893
·
Received December 20, 2012
Report
- Report Number
- 1644487-2012-03421
- Event Type
- Injury
- Date Received
- December 20, 2012
- Date of Event
- September 1, 2012
- Report Date
- November 21, 2012
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
CLINIC NOTES WERE RECEIVED FOR REVIEW REPORTING THAT A VNS PATIENT HAD SLEEP APNEA. THE START DATE OF THE EVENT AND THE RELATIONSHIP TO THEIR VNS THERAPY IS UNKNOWN AT THIS TIME. NO FURTHER INFORMATION HAS BEEN ATTAINED THUS FAR.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S REPORTED SLEEP APNEA WAS NOT VNS RELATED. THEIR VNS STIMULATION IS NOT AFFECTING IT. THEY WERE DIAGNOSED SOMETIME IN (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 103 | PULSE GEN MODEL 103 | LYJ | CYBERONICS, INC. | 103 | 2694 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other |