PULSE GEN MODEL 102R

MDR report key: 2922332 · Received January 18, 2013

Report

Report Number: 1644487-2013-00154
Event Type: Death
Date Received: January 18, 2013
Date of Event: September 20, 2010
Report Date: December 20, 2012
Manufacturer: CYBERONICS, INC.
Product Code: LYJ
PMA / PMN Number: P970003
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SD, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS OF PROGRAMMING HISTORY.

Description of Event or Problem · 1

REVIEW OF THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE SHOWED PROGRAMMING HISTORY UNTIL (B)(4) 2010 INDICATING THAT THE PATIENT PASSED AWAY AFTER THAT DATE. BASED ON THE LIMITED AVAILABLE INFORMATION ABOUT THE PATIENT'S DEATH, AN INTERNAL CLASSIFICATION HAS DETERMINED THAT THE DEATH MAY BE POSSIBLE SUDEP.

Description of Event or Problem · 1

THERE IS NO ADDITION INFORMATION THAT CAN BE ATTAINED. THE IS NO ADDITIONAL INFORMATION THAT IS KNOWN AND THERE IS NO ONE TO CONTACT FOR ADDITIONAL INFORMATION.

Description of Event or Problem · 1

IT WAS REPORTED ON (B)(4) 2012 THAT A VNS PATIENT PASSED AWAY DUE TO UNKNOWN REASONS. THE DATE OF DEATH AND THE PATIENT'S LAST TREATING PHYSICIAN IS UNKNOWN AT THIS TIME. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

Description of Event or Problem · 1

CAUSE OF DEATH INFORMATION OBTAINED FROM THE NATIONAL DEATH INDEX (NDI) WAS REVIEWED BY THE MANUFACTURER WHICH INDICATED THAT THE PATIENT PASSED AWAY ON (B)(6) 2010 AND THE PATIENT'S CAUSE OF DEATH WAS UNSPECIFIED DISORDER OF THE BRAIN, ACCOMPANIED BY OTHER AND UNSPECIFIED CONVULSIONS. THERE IS NO ALLEGATION OR OTHER INFORMATION INDICATING THAT THE DEATH IS RELATED TO VNS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
27160	PULSE GEN MODEL 102R	GENERATOR	LYJ	CYBERONICS, INC.	102R	010763

Patients

Seq	Age	Sex	Outcome	Treatment
1	28 YR		Death