FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2488171
·
Received March 12, 2012
Report
- Report Number
- 1644487-2012-00683
- Event Type
- Injury
- Date Received
- March 12, 2012
- Date of Event
- February 13, 2012
- Report Date
- February 14, 2012
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ALL FURTHER ATTEMPTS TO THE REPORTER REGARDING THE PATIENT'S SLEEP APNEA HAVE BEEN UNSUCCESSFUL TO DATE.
Description of Event or Problem · 1
REPORTER INDICATED VIA CLINIC NOTES RECEIVED TO THE MANUFACTURER THAT A VNS PATIENT HAS SLEEP APNEA AND USES C-PAP TREATMENT. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | PULSE GEN MODEL 102 | LYJ | CYBERONICS INC | 102 | 014097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |