FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1277570
·
Received December 18, 2008
Report
- Report Number
- 1644487-2008-03058
- Event Type
- Malfunction
- Date Received
- December 18, 2008
- Date of Event
- January 1, 2008
- Report Date
- November 21, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT THE PATIENT HAD HIGH LEAD IMPEDANCE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | MUZ | CYBERONICS, INC. | 302-20 | 1641 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |