FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 2181241
·
Received July 8, 2011
Report
- Report Number
- 1644487-2011-01528
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 7, 2011
- Report Date
- June 9, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S VNS INDICATED HIGH IMPEDANCE. X-RAYS TO SEARCH FOR A LEAD FRACTURE ARE PLANNED. SURGERY TO REPLACE THE PT'S LEAD IS LIKELY. NO ADVERSE EVENTS HAVE BEEN REPORTED. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 1934 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR |