It was reported that the patient had a condition of pseudotumor cerebri and was implanted with the device on (b)(6) 2012.The device was set to 2.5.Shortly after the surgery, the patient went back to the hospital due to symptoms.The healthcare professional (hcp) x-rayed the device and found that it was not set at 2.5.The clinicians set it back to 2.5 and the patient went home.Then in (b)(6) 2014, the patient became very ill, vomiting, and numbness.They went to the emergency room at the hospital where the hcp ran a shunt series.They found the device to be set at 0.5 and set it back to 2.5.One week later after being sent home, the patient was violently ill again, and they went back to the emergency room.The x-ray confirmed the device had moved to 1.0.The hcp concluded that the device was the issue so it was replaced with another device and set to 2.5 on (b)(6) 2016.It was noted the patient had not had any magnet resonance imaging (mri).
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