FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1213119
·
Received October 23, 2008
Report
- Report Number
- 1644487-2008-02563
- Event Type
- Malfunction
- Date Received
- October 23, 2008
- Date of Event
- January 1, 2006
- Report Date
- September 26, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PATIENT RECEIVED A HIGH LEAD IMPEDANCE WARNING DURING DIAGNOSTIC TESTING, WHICH PROMPTED THE TREATING PHYSICIAN TO DISABLE THE PATIENT DEVICE. THE FAMILY HAS INDICATED THAT THEY WOULD LIKE TO RESUME THERAPY AND THAT SURGERY MAY OCCUR. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 9728 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR |