PULSE GEN MODEL 102

Report

Report Number: 1644487-2011-01918
Event Type: Injury
Date Received: August 19, 2011
Date of Event: April 12, 2011
Report Date: July 22, 2011
Manufacturer: CYBERONICS INC
Product Code: LYJ
PMA / PMN Number: P970003
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, CYBERONICS, OR CYBERONICS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR MALFUNCTIONS. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND CYBERONICS OBJECTS TO THEIR USE.

Description of Event or Problem · 1

ON (B)(6) 2011, CLINIC NOTES FROM A VNS TREATING PHYSICIAN WERE RECEIVED THROUGH CASE MANAGEMENT. REVIEW OF THE CLINIC NOTES DATED (B)(6) 2011 REVEALED THAT THE PATIENT HAS BEEN EXPERIENCING SLEEP APNEA. THERE WAS NO MENTION IN THE CLINIC NOTES CONCERNING THE RELATIONSHIP OF THE PATIENT'S SLEEP APNEA TO VNS. ADDITIONAL INFORMATION REGARDING THE PATIENT'S SLEEP APNEA HAS BEEN REQUESTED FROM THE PHYSICIAN; HOWEVER NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. IF FURTHER INFORMATION IS RECEIVED, IT WILL BE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PULSE GEN MODEL 102	GENERATOR	LYJ	CYBERONICS INC	102	6822

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Required Intervention