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.The cause(s) of the difficulty reported by the customer could not be determined.If the 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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In the literature article ¿transanal protrusion of subdural peritoneal shunt in the setting of appendicitis¿ by joseph sujka, richard sola jr., and david juang, published journal of pediatric surgery case reports 34 (2018) 35¿36, it was reported that approximately 1 year post implantation, an unknown bactiseal peritoneal catheter migrated from the insertion site and was associated with pain, appendicitis, erosion through the bowel.The treatment for this event included externalization of the catheter, then followed by resection of the bowel and omentum and removal of the associated valve.Per the article: ¿we report a case of a transanal protrusion of a subdural peritoneal shunt in the setting of previous abdominal pain possibly consistent with acute appendicitis.While a report of transanal protrusion of a ventriculoperitoneal shunt via the appendix has been reported this is the first report where abdominal inflammation was also present.While patients with hollow organ perforation have been described as being managed conservatively after externalization of the proximal shunt and removal of the distal shunt, we managed our patient with an operation given our concern for appendicitis.¿ this is a 16 month old male child who received the vp shunt post non-accidental head trauma with chromic subdural hematoma.The decision to remove the scf valves was made because the chronic hematoma has resolved and there was minimal drainage after externalization of the system.At the time of complaint entry, no device specific information, i.E.Catalogue/lot number, is available.
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