It was reported that it was known prior to implant surgery that the patient had severe cardiac issues before implant, but the patient was still implanted due to the vns benefits outweighing the risks.However, the physicians had a suspicion that the patient may have some issues after the surgery.When the case manager called the patient's girlfriend on (b)(6) 2016 to follow-up on the appointment, it was reported that the patient was still in the hospital due to clotting issues.The patient was hospitalized three days before the implant due to heparin bridging.The day after implant on (b)(6) 2016, the patient had surgery to drain the generator incision site.The neck site was also swollen and was noted that it would probably need draining also.She stated that it is not infection.It was indicated that this is not due to the vns, but because of the clotting issues that patient has due to the heparin bridging.The patient was seen on (b)(6) 2016, and the device was turned on.The patient tolerated activation well.The clotting issues had appeared to resolve, and the patient appeared to be fine.It was clarified that the fluid was in the neck, and was since absorbing after the procedure.The physician thought that the clotting was blood.No additional relevant information has been received to date.
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