FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 2100268
·
Received May 16, 2011
Report
- Report Number
- 1644487-2011-01087
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Date of Event
- April 20, 2011
- Report Date
- April 20, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
ON (B)(6) 2011, A VNS TREATING PHYSICIAN REPORTED THAT THE PATIENT WAS SEEN THAT DAY AND SYSTEM DIAGNOSTICS PERFORMED SHOWED LOW IMPEDANCE. THE PATIENT IS ALSO EXPERIENCING AN INCREASE IN SEIZURES, BELOW PRE-VNS BASELINE LEVELS. THE PHYSICIAN PROGRAMMED THE PATIENT TO 0MA AT THE END OF THE VISIT. THE LAST TIME THE PATIENT WAS SEEN WAS ON (B)(6) 2010. THE PHYSICIAN HAD TURNED THE PATIENT'S DEVICE OUTPUT CURRENT UP BUT DID NOT PERFORM DEVICE DIAGNOSTICS. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE PATIENT'S PHYSICIAN HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 1290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female |