FDA Adverse Event
Injury
Summary report: N
LEAD MODEL UNKNOWN
MDR report key: 4113796
·
Received September 24, 2014
Report
- Report Number
- 1644487-2014-02448
- Event Type
- Injury
- Date Received
- September 24, 2014
- Date of Event
- August 27, 2014
- Report Date
- August 27, 2014
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VNS PATIENT HAD DEVELOPED AN INFECTION AT HIS NECK INCISION SITE AND WAS EXPERIENCING VOICE ALTERATION AND PAINFUL STIMULATION. THE PATIENT HAD BEEN IMPLANTED WITH VNS FOR OVER A YEAR. NO FURTHER INFORMATION RELEVANT TO THE EVENT HAS BEEN RECEIVED TO DATE.
Description of Event or Problem · 1
IT WAS IDENTIFIED THAT A DUPLICATE REPORT OF THIS PATIENT'S INFECTION WAS SUBMITTED IN MFG REPORT #: 1644487-2014-02440. MANUFACTURER REPORT # 1644487-2014-02440 WILL HOUSE ANY FUTURE INFORMATION RELATED TO THE INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 595093 | LEAD MODEL UNKNOWN | LEAD | LYJ | CYBERONICS, INC. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |