Catalog Number XXX-HAKIM PROGRAMMABLE VALVE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Nausea (1970)
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Event Date 12/02/2021 |
Event Type
Injury
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.
Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A physician reported a (b)(6) valve was implanted in a (b)(6) male via vp shunt on (b)(6) 2018 with setting (b)(4).
The pressure changed and it was possible to change it; however, the valve was removed and replaced on (b)(6) 2021 due to nausea symptom.
According to the physician, the patient seemed to hit his head while sleeping, and it was possible that the parts inside the valve were damaged.
Patient is recovered.
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.
Upon completion of the investigation, a follow-up report will be submitted.
|
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Event Description
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A physician reported a hakim valve was implanted in a (b)(6) male via vp shunt on (b)(6) 2018 with setting 120mmh2o.
The pressure changed and it was possible to change it; however, the valve was removed and replaced on (b)(6) 2021 due to nausea symptom.
According to the physician, the patient seemed to hit his head while sleeping, and it was possible that the parts inside the valve were damaged.
Patient is recovered.
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Search Alerts/Recalls
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