FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1890925
·
Received October 28, 2010
Report
- Report Number
- 1644487-2010-02417
- Event Type
- Malfunction
- Date Received
- October 28, 2010
- Date of Event
- September 1, 2010
- Report Date
- October 1, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED.
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE VNS PATIENT WAS HAVING AN INCREASE IN SEIZURES. ACCORDING TO PATIENT'S CAREGIVER (MOTHER), THE PATIENT FELL DOWN 2 WEEKS PRIOR TO THE TIME WHEN AN INCREASE IN SEIZURE WAS OBSERVED. THE DEVICE HAS BEEN DISABLED AFTER HIGH LEAD IMPEDANCE WAS OBSERVED. THE PATIENT HAS ALSO BEEN REFERRED FOR REVISION SURGERY. 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 | 1403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |