FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1172159
·
Received September 11, 2008
Report
- Report Number
- 1644487-2008-02230
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- January 1, 2008
- Report Date
- May 20, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS HAVING REVISION SURGERY DUE TO END OF SERVICE AND A POTENTIAL LEAD BREAK. ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE NEUROLOGIST WERE UNSUCCESSFUL. PRODUCT ANALYSIS WAS PERFORMED ON THE EXPLANTED LEAD. A COIL BREAK AND PITTING WAS IDENTIFIED IN THE POSITIVE COIL. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ADVERSE FINDINGS, OR ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 5213 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |