FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1993853
·
Received February 11, 2011
Report
- Report Number
- 1644487-2011-00253
- Event Type
- Injury
- Date Received
- February 11, 2011
- Date of Event
- January 14, 2011
- Report Date
- January 14, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT A VNS PT WAS BEING REFERRED FOR PROPHYLACTIC REPLACEMENT OF HIS GENERATOR. CLINIC NOTES WERE RECEIVED DATED (B)(6) 2010 INDICATING THE PT WAS HAVING EPISODES OF DAILY SCREAMING ALONG WITH INTERMITTENT BEHAVIORAL ISSUES. FURTHERMORE, INFO ON AN INSURANCE FORM INDICATED THE PT HAD USED INSURANCE FOR SYNCOPE AND COLLAPSE ON (B)(6) 2010. AT THE MOMENT, THE RELATIONSHIP OF THE SYNCOPE AND COLLAPSE TO VNS THERAPY IS UNK. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE TREATING NEUROLOGIST 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 | 009728 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Required Intervention |