FDA Adverse Event
Injury
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 2161854
·
Received July 8, 2011
Report
- Report Number
- 1644487-2011-01531
- Event Type
- Injury
- Date Received
- July 8, 2011
- Date of Event
- October 13, 2010
- Report Date
- June 10, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED FOLLOWING EXPLANT SURGERY THAT THE PATIENT WAS HAVING VOCAL CORD ISSUES AND TROUBLE SWALLOWING. THE PATIENT IS CURRENTLY NOT IMPLANTED WITH ANY VNS DEVICES. THE PATIENT SAW AN ENT PHYSICIAN AND RECEIVED A MICRO DL. THE PATIENT IS NOW DOING WELL WAS SWALLOWING FOOD BUT IS STILL HAVING PROBLEMS WITH LIQUIDS. THE PATIENT HAS NOT HAD THEIR VNS DEVICES REPLACED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Required Intervention |