MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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Model Number 27819 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Dizziness (2194); Complaint, Ill-Defined (2331); Irritability (2421)
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Event Date 01/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient was implanted with a pressure adjustable shunt on (b)(6) 2016 due to hydrocephalus.In (b)(6) 2017, the patient began to feel dizzy and the brain had a sound of water.After the patient went to the hospital in february to have the pressure adjusted, the doctor suggested to be observed for a period of time.In (b)(6) 2018, the patient was feeling irritable, had dizziness, and frequent water sound in the brain.The patient immediately went to the hospital for a brain ct examination, and the doctor judged that it might be caused by over shunting.It was recommended to have the pressure adjusted.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information reported that the patient had not contacted the physician for the adjustment, and since there was no contact, no additional information was able to be provided about the patient.It was also stated that the doctor didn't have any doctor's order so there was no pressure adjustment.
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Search Alerts/Recalls
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