FDA Adverse Event
Injury
Summary report: N
LEAD MODEL 304
MDR report key: 4928722
·
Received July 21, 2015
Report
- Report Number
- 1644487-2015-05214
- Event Type
- Injury
- Date Received
- July 21, 2015
- Date of Event
- April 14, 2015
- Report Date
- June 22, 2015
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
THE PROVIDER INDICATED THAT THE PATIENT'S VOICE HAD IMPROVED BUT WAS NOT BACK TO 100%. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. NO KNOWN INTERVENTIONS HAVE OCCURRED TO DATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT HAD VOCAL CORD PARALYSIS WHICH STARTED ON THE DAY THE PATIENT UNDERWENT VNS SURGERY. LEAD IMPEDANCE WAS NOTED TO BE WITHIN NORMAL LIMITS AT IMPLANT SURGERY. THE PATIENT WAS REFERRED TO AN EAR, NOSE AND THROAT PHYSICIAN FOR EVALUATION AND IS ALSO PLANNING TO FOLLOW-UP WITH HER IMPLANTING SURGEON. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471011 | LEAD MODEL 304 | LEAD | LYJ | CYBERONICS, INC. | 304-30 | 203085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |