FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1172591
·
Received September 19, 2008
Report
- Report Number
- 1644487-2008-02272
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- January 1, 2003
- Report Date
- August 21, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVIEW OF PATIENT'S DEVICE PROGRAMMING HISTORY REVEALED A HIGH LEAD IMPEDANCE EVENT IN 2003. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THE EVENT HAVE BEEN UNSUCCESSFUL TO DATE.
Description of Event or Problem · 1
THIS REPORT WAS IDENTIFIED AS A DUPLICATE OF MFR. REPORT #1644487-2008-02100. ALL ADDITIONAL INFORMATION WILL BE REPORTED IN MFR. REPORT #1644487-2008-02100.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 5262 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |