FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 2257513
·
Received August 26, 2011
Report
- Report Number
- 1644487-2011-02007
- Event Type
- Malfunction
- Date Received
- August 26, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 27, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS REFERRED FOR X-RAYS DUE TO SOME NAUSEA, WHICH SHOWED THAT THE LEADS WERE LOOSE ACCORDING TO THE X-RAY TECH. IT IS NOT CLEAR WHAT THEY VISUALIZED OR HOW THIS WAS DETERMINED. IT WAS ALSO NOTED THAT AFTER ECT TREATMENT IN (B)(6), PREVIOUS NAUSEA WAS RESOLVED. PT CAME IN DUE TO X-RAYS AND HIGH LEAD IMPEDANCE. THE PT IS SCHEDULED FOR REVISION SURGERY, BUT IT HAS NOT OCCURRED TO DATE. ATTEMPTS FOR FURTHER INFO 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 | 1350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Male |