FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 3160054
·
Received June 10, 2013
Report
- Report Number
- 1644487-2013-01734
- Event Type
- Injury
- Date Received
- June 10, 2013
- Report Date
- May 13, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
CLINIC NOTES DATED (B)(6), 2013 WERE RECEIVED WHICH INDICATE THAT THE PATIENT HAS SEVERE OBSTRUCTIVE SLEEP APNEA. THE NOTES STATE THAT THE PATIENT USES CPAP INTERMITTENTLY FOR THE SLEEP APNEA AND THA TTHE PATIENT'S SLEEP IS POOR. ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION. THE PHYSICIAN STATED THAT THE VNS BATTERY IS DEAD AND THE EVENT IS UNRELATED TO VNS. NO OTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260703 | PULSE GEN MODEL 103 | GENERATOR | LYJ | CYBERONICS INC | 103 | 200969 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |