Catalog Number 82-3192 |
Device Problems
Device Displays Incorrect Message (2591); Programming Issue (3014)
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Patient Problem
No Information (3190)
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Event Date 09/07/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Both 510(k) #'s for this product code: k061876 & k050739.Upon completion of the investigation, a follow up report will be filed.
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Event Description
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Elsg tage report vpv valve programmer repair of unit description of failure: as before - programmer sometimes the valve programs then says programming failed and try again, however it is setting the valve but sometimes it fails.Patient has to go for x- ray to confirm.Device error message: no other information available.When was the problem discovered?: pre-operatively.Surgical delay?: none.
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Manufacturer Narrative
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It has been discovered that the report associated with this event is a duplicate of that filed under mdr 26348-2016-10680.Please refer to that report for information regarding the reported event.
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Search Alerts/Recalls
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