FDA Adverse Event Injury Summary report: N

LEAD MODEL UNKNOWN

MDR report key: 2001039 · Received February 21, 2011

Report

Report Number
1644487-2011-00317
Event Type
Injury
Date Received
February 21, 2011
Date of Event
January 1, 2011
Report Date
February 1, 2011
Manufacturer
CYBERONICS, INC.
Product Code
LYJ
PMA / PMN Number
P970003
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
HU
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PT HAD EXPERIENCED VOCAL CORD PARALYSIS. NO FURTHER INFO WAS GIVEN. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LEAD MODEL UNKNOWN LYJ CYBERONICS, INC.

Patients

Seq Age Sex Outcome Treatment
1