FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1220053
·
Received October 31, 2008
Report
- Report Number
- 1644487-2008-02650
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 3, 2008
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS: DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT DURING SURGERY, IT WAS NOTED THAT THERE WAS BODILY FLUID PRESENT BETWEEN THE INNER AND OUTER TUBING ON THE LEAD. DIAGNOSTICS WERE PERFORMED AND ALL WERE OK, SO IT WAS DECIDED THAT THE LEAD WOULD BE LEFT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS INC | 302-20 | 10960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR |