FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1834514
·
Received September 10, 2010
Report
- Report Number
- 1644487-2010-02071
- Event Type
- Malfunction
- Date Received
- September 10, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 12, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS: DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VNS PATIENT WAS REFERRED TO THE SURGEON DUE TO A RECENT INCREASE IN SEIZURE ACTIVITY, AND POSSIBLE HIGH LEAD IMPEDANCE RESULT FROM A DIAGNOSTIC TEST NOTED AT A FOLLOW UP VISIT. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE CURRENTLY UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 1937 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention |