Reporter indicated a vns therapy pt "decided to remove the battery himself.
He literally removed the battery including the leads", and the incision became infected.
The physician did not know the pt removed the vns therapy system.
The pt's family reports the pt "has been doing strange things", since his medications were changed.
Mfr records confirmed device sterility prior to shipment.
The explanted vns therapy system has been returned to the mfr and is pending analysis.
Good faith attempts to obtain add'l info have been unsuccessful to date.