FDA Adverse Event
Injury
Summary report: N
VNS THERAPY LEAD
MDR report key: 526050
·
Received May 20, 2004
Report
- Report Number
- 1644487-2004-00462
- Event Type
- Injury
- Date Received
- May 20, 2004
- Date of Event
- March 2, 2004
- Report Date
- April 8, 2004
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT PT WAS EXPERIENCING BOTHERSOME HOARSENESS AND TROUBLE SWALLOWING AFTER VNS IMPLANT. STIMULATION WAS INITIATED TWO WEEKS AFTER IMPLANT. STIMULATION WAS INITIATED TWO WEEKS AFTER IMPLANT. LARYNGOSCOPY REVEALED THAT THE PT'S RIGHT VOCAL CORD WAS NOT WORKING. TREATING NEUROLOGIST INDICATED THAT THE EVENT WAS RELATED TO THE VNS. FURTHER FOLLOW-UP REVEALED THAT THE PT WAS DOING BETTER, ONLY COUGHING OCCASIONALLY AND THAT THEIR VOICE HAD ALMOST RETURNED BACK TO NORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VNS THERAPY LEAD | BIPOLAR LEAD | LYJ | CYBERONICS, INC. | 302-20 | 9597 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Disability | MODEL 102 VNS THERAPY PULSE, EXPIR DATE 10/31/2005| DATE OF MFG 11/18/2003, STERILIZATION LOT# 9597. |