PULSE GEN MODEL 102

Report

Report Number: 1644487-2011-02042
Event Type: Injury
Date Received: September 1, 2011
Date of Event: January 1, 2011
Report Date: August 5, 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: NURSE

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

MANUFACTURER FOLLOW-UP WITH THE HOSPITAL REVEALED THE EXPLANTED VNS GENERATOR WAS DISCARDED.

Description of Event or Problem · 1

CLINICAL NOTES WERE RECEIVED TO THE MANUFACTURER INDICATING A VNS PATIENT HAD A HISTORY OF STROKE. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.

Description of Event or Problem · 1

REPORTER INDICATED THE PATIENT HAD VNS GENERATOR REPLACEMENT SURGERY PERFORMED. ALL ATTEMPTS TO THE REPORTER FOR FURTHER INFORMATION REGARDING THE STROKE HAVE BEEN UNSUCCESSFUL TO DATE. ATTEMPTS FOR RETURN OF THE EXPLANTED VNS GENERATOR ARE IN PROGRESS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PULSE GEN MODEL 102	PULSE GEN MODEL 102	LYJ	CYBERONICS INC	102	014675

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR		Required Intervention