MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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Model Number UNKNOWN-S |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Edema (1820); Therapeutic Effects, Unexpected (2099)
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Event Date 08/01/2019 |
Event Type
Injury
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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 the patient was implanted with a pressure regulator valve due to hydrocephalus.In (b)(6) 2019, there was a situation of edema that happened on the patient.The patient was hospitalized and underwent ct examination.The ct examination's results were showed to the surgeon, and the doctor said that the drainage was excessive.It was recommended to increase the patient's pressure by one level.The patient's pressure at discharge was 1.0.It was stated that if there was no change in the current pressure position, adjust to 1.5.Currently, the patient was hospitalized.
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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 received reported that on august 19, 2019, the manufacturer representative adjusted the pressure for the patient at the hospital, and it resolved the event.
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Search Alerts/Recalls
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