Additional information received from the patient¿s attorney reported that following the placement of the implant in (b)(6) 2016, the valve failed and caused the patient to experience serious adverse symptoms, including severe headaches, nausea, vomiting, and lethargy.It was further stated that the defective valve caused the patient to undergo hospitalization and corrective surgeries, including the removal of the failed implant and placement of a new implant.
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Additional information received reported that between the dates of (b)(6) 2016 to (b)(6) 2016, the patient presented to the emergency room (er) with severe headache, nausea, light sensitivity, vomiting, and ear pain.Ct showed increased ventricular size and hemorrhage with increased blood layering around ventricular catheter.The patient was taken to the operating room, and the ventricular shunt catheter was repositioned.On (b)(6) 2016, the patient presented to the er again with severe headache, nausea, vomiting, and hearing/vision changes.Imaging results were returned unremarkable.On (b)(6) 2016, the patient had another er visit with a complaint of headaches, dizziness, weakness, distorted vision, and shunt malfunction.These symptoms were similar to previous episodes and were alleviated by nothing.The patient was admitted to evaluate the shunt malfunction.They were given a lumbar puncture.Imaging results returned unremarkable.Between the dates of (b)(6) 2016 to (b)(6) 2016, the patient visited the hospital with complaints of dizziness, right head tingling, vision changes, hearing issues, and shunt malfunction.Imaging results returned stable and unr emarkable on (b)(6) 2016 and (b)(6) 2016.Symptoms were alleviated after they received a lumbar puncture.On (b)(6) 2016, the patient had a follow-up visit at the neurology clinic.They stated their headaches were better, but their vision was blurry on the right and their hearing was worse.Between the dates of (b)(6) 2016 to (b)(6) 2016, the patient presented to the er with complaints of headaches, loss of coordination of the tongue, peripheral vision loss, muffled hearing, numbness, and loss of grip.Imaging results unremarkable and unchanged.The shunt was reprogrammed, and the patient received a lumbar puncture.On (b)(6) 2016, they had a follow-up visit at the neurology clinic where they stated their headaches were worse so they requested a shunt reprogramming.On (b)(6) 2016, the patient had another follow-up visit at the neurology clinic where they had complaints of hearing loss and ear pressure.Between the dates of (b)(6) 2016 to (b)(6) 2016, the patient visited the hospital with complaints of headache, vision loss, nausea, and vomiting.The vision problems occur constantly and gradually worsen.Progress notes stated that their headaches were mostly on the right side, and they heard their heartbeats in their ears.The symptoms worsened while bending over.Imaging results returned unremarkable/unchanged.Between the dates of (b)(6) 2016 to (b)(6) 2016, the patient was admitted to the hospital for monitoring after presenting to the er.The chief complaint was unspecified type of headache and shunt malfunction.The patient stated they had a headache for 3 days and would not get better.Their right vision was more blurry and their right ear felt clogged.Imaging was suggestive of overdraining.On (b)(6) 2017, the patient visited the neurology clinic with complaints of long-lasting headaches.The doctors treated them for migraines.Between the dates of (b)(6) 2017 to (b)(6) 2017, the patient presented at the er and was admitted.The patient had fallen twice in the same day.They also complained of worsening headaches and nausea.It was confirmed that the pressure settings were changing on their own.On (b)(6) 2017, the patient visited the neurology clinic with complaints of hearing and vision problems from increased intracranial pressure.The shunt was found to be set at 2 and therefore reset to 1.On (b)(6) 2017, the patient visited the neurology clinic again with complaints of headaches, nausea, and vomiting.They also complained that they continued to hear the clicking sounds of the neurological device.The settings continued to change without the presence of any magnets near them.Shunt interrogation found the setting to be at 2.It was reset to 1.On (b)(6) 2017, the patient presented to the er and was admitted for worsening headaches and their shunt was malfunctioning.Symptoms included nausea, vomiting, hearing and vision impairment with gait imbalance.On (b)(6) 2017, the valve was replaced.
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