FDA Adverse Event
Injury
Summary report: N
LEAD MODEL 302
MDR report key: 1651539
·
Received April 2, 2010
Report
- Report Number
- 1644487-2010-00808
- Event Type
- Injury
- Date Received
- April 2, 2010
- Date of Event
- March 5, 2010
- Report Date
- March 5, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYZ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED A VNS PT HAD DEVELOPED VOCAL CORD PARESIS, AND THAT THE PT HAS HAD THE PROBLEM SINCE THE VNS WAS IMPLANTED ON (B) (6) 2009. THE VNS WAS NOT TURNED ON UNTIL EARLY (B) (6) 2010, BUT THE REPORTER INDICATED THE VNS WOULD BE DISABLED AT THE PT'S OFFICE VISIT THE FOLLOWING WEEK AS THE PARESIS WORSENED SLIGHTLY WITH VNS STIMULATION. THE REPORTER BELIEVES THE VOCAL CORD PARESIS WAS CAUSED BY THE INITIAL VNS IMPLANT SURGERY, AND NOT BY THE VNS STIMULATION. ATTEMPTS TO THE REPORTER FOR FURTHER INFO ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYZ | CYBERONICS, INC. | 302-20 | 201164 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention |