It was reported to medtronic neurosurgery that the patient had the device installed on (b)(6) 2011.According to the report, after 27 revisions due to shunt malfunction varying from tubing coming loose, to tubing tangled in the abdominal cavity, and to magnetic field setting not setting properly, they had the shunt removed on (b)(6) 2011.However, it was stated that the patient's problems didn't cease to exist, and they developed a spinal fluid leak at the abdominal and back incision site.They were admitted into the hospital for almost 6 months and had nurses, doctors, and interns come in every 30 minutes to push fluid out, change sheets 20-30 times a day, and have several "gauze packing attempts" only to be sent home with a home health nurse and iv rocephin administered daily due to the continual gushing of the spinal fluid out of their spine and abdomen.It was stated they were so drugged up that they did not realize what was happening, and one day finally asked them to the nurses to please use gloves when trying to extract spinal fluid.Reportedly, at one point, the patient had a softball size knot appear on their spine and at the valve site that eventually ruptured and gushed spinal fluid everywhere.It was stated since removal, they have had non stop problems, and even developed an additional spinal leak that had to be repaired by the doctor in 2015.Prior to repairing the leak the patient was unable to stand for longer than 2-3 minutes at a time and was leaking spinal fluid in the back and backing up, dripping out of their nose.It was noted that by accident when they went to the emergency room complaining of right abdominal swelling, shortness of breath, headache, and extreme altered vision that they did a ct of the abdomen.It revealed a 18 inch section of tubing from the device was still left inside the patient and was located between l1 and s2 and was pressing on a nerve to their left leg causing a constant feeling of the leg being on fire.The patient went back to the neurosurgeon who initially installed and removed the device, and they were informed portion of the tubing had broken off during removal.It was stated there was nothing the neurosurgeon could to about it and it was irremovable from the spine.
|