FDA Adverse Event Death Summary report: N

PULSE GEN MODEL UNKNOWN

MDR report key: 1706380 · Received May 28, 2010

Report

Report Number
1644487-2010-01283
Event Type
Death
Date Received
May 28, 2010
Date of Event
April 1, 2010
Report Date
April 28, 2010
Manufacturer
CYBERONICS, INC.
Product Code
LYJ
PMA / PMN Number
P970003
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FI
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT HAD DIED AT HOME IN (B) (6) 2010, DUE TO AN UNK REASON. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 Death