FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1191919
·
Received October 1, 2008
Report
- Report Number
- 1644487-2008-02370
- Event Type
- Malfunction
- Date Received
- October 1, 2008
- Date of Event
- July 3, 2008
- Report Date
- September 4, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 PT HAD HER LEAD REPLACED DUE TO HIGH LEAD IMPEDANCE. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO FOR THE SITE AS WELL AS THE EXPLANTED LEAD BACK FOR PRODUCT ANALYSIS 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 | 19 YR |