FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1132646
·
Received August 22, 2008
Report
- Report Number
- 1644487-2008-01995
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- July 24, 2008
- Report Date
- July 24, 2008
- 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 A VNS PATIENT WAS HAVING INCREASED SEIZURES. THE REPORTER WAS UNABLE TO INTERROGATE THE PATIENT'S VNS GENERATOR AND BELIEVED IT WAS AT END OF SERVICE. THE PATIENT LATER UNDERWENT VNS GENERATOR REPLACEMENT SURGERY. THE EXPLANTED GENERATOR HAS BEEN RETURNED AND IS CURRENTLY IN PRODUCT ANALYSIS. ALL FURTHER ATTEMPTS FOR INFORMATION FROM THE REPORTER HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 011003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |