FDA Adverse Event
Injury
Summary report: N
LEAD MODEL 304
MDR report key: 2963960
·
Received February 15, 2013
Report
- Report Number
- 1644487-2013-00417
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- December 27, 2012
- Report Date
- January 17, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
VNS LEAD PRODUCT INFORMATION WAS OBTAINED FROM THE IMPLANTING HOSPITAL.
Description of Event or Problem · 1
REPORTER INDICATED A VNS PATIENT DEVELOPED LEFT VOCAL CORD PARALYSIS 3 DAYS AFTER INITIAL VNS IMPLANT SURGERY ON (B)(6) 2012. THE LEFT VOCAL CORD PARALYSIS IS FELT TO LIKELY BE RELATED TO THE IMPLANT PROCEDURE. THE VNS STIMULATION HAS NOT BEEN ENABLED YET. CONSULTATION WITH AN ENT PHYSICIAN INCLUDED VIDEO STROBOSCOPY, WHICH IDENTIFIED LEFT VOCAL FOLD PARESIS, OTHERWISE THE HEAD AND NECK EXAM WERE UNREMARKABLE. SPEECH THERAPY IS PLANNED AS AN INTERVENTION, WHICH MAY HELP THE HEALING PROCESS AND ASSIST WITH SYMPTOMS. THE PATIENT'S VOCAL CORD IS EXPECTED TO RETURN TO NORMAL FUNCTION. ATTEMPTS FOR VNS PRODUCT INFORMATION ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68592 | LEAD MODEL 304 | LEAD | LYJ | CYBERONICS INC | 304-20 | 202157 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Required Intervention |