It was reported that the vns patient recently underwent emergency surgery not related to vns.The patient¿s device subsequently showed a low battery condition during an office visit on (b)(6) 2014.It is believed that during the patient¿s non-vns surgery, electrocautery was used which hit the generator and depleted the battery.An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2014.The explanting facility discarded the explanted device; therefore, no analysis can be performed.
|