FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2656871
·
Received July 16, 2012
Report
- Report Number
- 1644487-2012-01793
- Event Type
- Injury
- Date Received
- July 16, 2012
- Date of Event
- June 17, 2012
- Report Date
- June 21, 2012
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT A VNS PATIENT EXPERIENCED VOICE ALTERATION AND ASPIRATION DUE TO UNKNOWN REASON. THE PATIENT WAS REFERRED TO AN ENT AND AT THE MOMENT ARE PENDING RESULTS FROM EVALUATION. MOREOVER, INFORMATION FROM THE TREATING NEUROLOGIST INDICATED THE GENERATOR WAS OFF AT THE TIME OF THE EVENTS. THE PATIENT HAD LITTLE DYSPHONIA WHICH HAS DISAPPEARED. CORTICOSTEROID THERAPY WAS STARTED AND THE VOICE HAD ALMOST NORMALIZED. ASPIRATION WAS FOUND BY ENT PHYSICIAN AND A REPORTED SWALLOWING DIFFICULTY WAS PRESENT PRE-VNS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | GENERATOR | LYJ | CYBERONICS INC | 102 | 202060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |