Model Number UNKNOWN-S |
Device Problems
Use of Incorrect Control/Treatment Settings (1126); Mechanics Altered (2984)
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Patient Problems
Headache (1880); Dizziness (2194)
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Event Type
Injury
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Manufacturer Narrative
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This event was reported on an online forum and provided to the manufacturer by a separate patient.No further information is available.The country the event occurred in is unknown.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 had the valve for 2 years.It was stated the patient experienced headaches and dizziness since implant.During the first post-operative visit it was determined that valve had reset itself.On several other occasions, the valve was found to be at the wrong setting.Eventually, the valve could no longer be set on anything but the highest and lowest setting.The valve was replaced with a fixed pressure valve.
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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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Search Alerts/Recalls
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