FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2190939
·
Received July 29, 2011
Report
- Report Number
- 1644487-2011-01702
- Event Type
- Injury
- Date Received
- July 29, 2011
- Date of Event
- June 7, 2011
- Report Date
- June 30, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED IN A PT'S CLINIC NOTES THAT IN LATE APRIL AND EARLY (B)(6) 2011, THE PT EXPERIENCED TWO "FLURRIES" OF SEIZURES. THE PT SAW A PHYSICIAN AT THIS TIME WHO ADJUSTED HIS VNS SETTINGS. THE PHYSICIAN NOTED THAT THE PT HAD NO OTHER SEIZURES SINCE (B)(6) 2011. THE PT'S LAST KNOWN DIAGNOSTICS ON (B)(6) 2010 SHOWED PROPER DEVICE FUNCTION. THE PT WAS REFERRED FOR A PROPHYLACTIC REPLACEMENT. ATTEMPTS FOR FURTHER INFO 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 | 2565 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |