FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2052577
·
Received April 8, 2011
Report
- Report Number
- 1644487-2011-00754
- Event Type
- Injury
- Date Received
- April 8, 2011
- Date of Event
- March 27, 2007
- Report Date
- March 10, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT A VNS PATIENT HAD A HISTORY OF MODERATE OBSTRUCTIVE SLEEP APNEA SINCE AT LEAST (B)(6) 2007. THE PATIENT USES A C-PAP MACHINE FOR THE SLEEP APNEA. THE PATIENT RECENTLY HAD VNS GENERATOR REPLACEMENT SURGERY DUE TO END OF SERVICE. ATTEMPTS FOR FURTHER INFORMATION AND RETURN OF THE EXPLANTED GENERATOR ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 011406 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Required Intervention |