FDA Adverse Event
Injury
Summary report: N
LEAD MODEL 304
MDR report key: 5194054
·
Received November 1, 2015
Report
- Report Number
- 1644487-2015-06292
- Event Type
- Injury
- Date Received
- November 1, 2015
- Date of Event
- July 24, 2015
- Report Date
- October 6, 2015
- Manufacturer
- CYBERONICS - HOUSTON
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING GENERATOR AND LEAD REPLACEMENT SURGERY (CAPTURED IN MANUFACTURER REPORT #1644487-2015-05156), THE VNS PATIENT BEGAN EXPERIENCING VOCAL ISSUES. THE PATIENT WAS EVALUATED BY ENT AND DIAGNOSED WITH LEFT VOCAL CORD PARALYSIS. IT WAS NOTED THAT THE LEFT VOCAL CORD WAS BEING WELL COMPENSATED BY THE RIGHT VOCAL CORD AND THAT THE PATIENT'S VOICE HAD BEEN GETTING STRONGER. NO INTERVENTIONS WERE TAKEN. THE VOCAL ISSUES WERE NOT OCCURRING WITH STIMULATION AND DEVICE DIAGNOSTICS SHOWED NORMAL DEVICE FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724079 | LEAD MODEL 304 | LEAD | LYJ | CYBERONICS - HOUSTON | 304-20 | 4215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Other |