It was reported that a patient was not receiving efficacy from the vns device.It was later reported that the patient's mother believed the vns device was making the patient's seizures worse.The device history record for the implanted generator showed that the generator had passed all quality inspections prior to release for distribution.Post-op impedance values for the device were also within normal limits, indicating the device was working as intended after surgery.No further relevant information has been received to date.No surgical intervention has occurred to date.
|