Catalog Number 82-3844 |
Device Problem
Programming Issue (3014)
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Patient Problems
Neurological Deficit/Dysfunction (1982); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Upon completion of the investigation, a follow up report will be filed.
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Event Description
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As reported by the ous sales rep, chpv inline valves w/o siphonguard changed their setting after patients left the hospital.There were no reports of delay or patient harm.
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Event Description
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As reported by the ous sales rep, chpv inline valves w/o siphonguard had unexpected setting changes after implantation.It was reported that the valve had to be reprogrammed and that the patient had symptoms associated to this event.
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Manufacturer Narrative
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Updated udi : (b)(4).It was initially reported that the device would be returned for evaluation.It was later communicated that the device would not be returned.Additional event information was received from the initial reporter.This report has been updated to reflect the updated information.Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released to stock.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.
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Search Alerts/Recalls
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