It was reported that the vns epilepsy pt passed away.
The physician informed the mfr that the cause of death was sudep.
Treating physician reported that the pt's generator was inadvertently programmed off and determined that the pt was without vns therapy for approx 5 months (refer to mfg report # 1644487-2008-01741).
Pt's device was then programmed back on to 0.
The pt passed away the following day.
An autopsy was performed.
The treating physician reported that death was not related to vns therapy.
Pt's generator and lead were explanted after death and returned to the mfr.
Analysis on the returned generator has been completed.
There were no performance or any adverse conditions found with the pulse generator during lab analysis.
Prod analysis on the explanted lead is pending.
Good faith attempts to obtain autopsy results and programming history have been unsuccessful to date.