As reported by the sales rep, on x-ray, it appears that the valve's stator became dislodged.Initially the pas were unable to read the valve.Another image was taken to see if they could get a better reading.No adverse consequences were reported.To date there has been no treatment or revision for this event.
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It has been communicated that the device remains implanted.To date, no additional intervention or revision has been performed.Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.X-ray images were provided for evaluation; however, no conclusion could be reached based on those images.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information 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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