FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 2191216
·
Received July 19, 2011
Report
- Report Number
- 1644487-2011-01613
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- January 1, 2011
- Report Date
- June 21, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE PT HAD A SURGICAL CONSULT FOR A FULL REVISION. THE REASON FOR THE FULL REVISION WAS UNK. FOLLOW-UP INDICATED THAT HIGH IMPEDANCE HAD BEEN RECEIVED AT AN OFFICE VISIT. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR |