FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1181588
·
Received September 25, 2008
Report
- Report Number
- 1644487-2008-02323
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- June 13, 2008
- Report Date
- August 27, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS: DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED TO THE MANUFACTURER VIA AN IMPLANT CARD THAT THE VNS PATIENT WENT THROUGH A FULL REVISION DUE TO END OF SERVICE OF THE GENERATOR. FOLLOW-UP REVEALED THAT THE LEAD WAS REPLACED DUE TO A LEAD FRACTURE AND THE GENERATOR WAS NOT AT END OF SERVICE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT ARE UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 3536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR |