FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1172601
·
Received September 19, 2008
Report
- Report Number
- 1644487-2008-02285
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- January 1, 2006
- Report Date
- August 20, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NURSE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD HIGH LEAD IMPEDANCE DCDC 7. IT IS UNKNOWN ON WHAT TEST. ALSO REPORTED THAT PATIENT WAS "NOT DOING WELL." THE SITE INDICATED THAT X-RAYS WOULD BE TAKEN AND SENT TO MANUFACTURE TO REVIEW AND THUS FAR NO X-RAYS HAVE BEEN RECEIVED. GOOD FAITH ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL DETAILS ABOUT EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 1541 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female |