FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 302
MDR report key: 880133
·
Received September 15, 2006
Report
- Report Number
- 1644487-2006-00340
- Event Type
- Malfunction
- Date Received
- September 15, 2006
- Report Date
- June 22, 2006
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- p970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF X-RAYS BY MANUFACTURER DID NOT REVEAL ANY OBVIOUS DISCONTINUITIES IN THE NCP SYSTEM. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OF CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT SYSTEMS DIAGNOSTICS TESTING AT OFFICE VISIT RESULTED IN HIGH LEAD IMPEDANCE READINGS, INDICATING POSSIBLE DEVICE MALFUNCTION. THE REPORTER REPLACED THE ENTIRE VNS SYSTEM DUE TO INTRAOPERATIVE HIGH IMPEDANCE. REVIEW OF X-RAYS BY TREATING SURGEON DID NOT REVEAL ANY OBVIOUS DISCONTINUITIES IN THE NCP SYSTEM. NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 302 | LYJ | LYJ | CYBERONICS, INC. | 302-20 | 009597 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |