Udi: unknown part number, attempts to obtain product were unsuccessful, udi unavailable.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 additional relevant information becomes available in the future, 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.This event was reported via a literature article.Refer to mdrs 1226348-2018-10849, 1226348-2018-10850, 1226348-2018-10851 for information regarding the additional events.
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In the literature article ¿analysis of codman microcerebrospinal fluid shunt¿ by axel sandvig | kai arnell | jan malm | anders eklund | lars-owe d.Koskinen, published brain and behavior.2018;8:e01002.Https://doi.Org/10.1002/brb3.1002, it was reported that implantation of unknown codman hakim valves, 4 patient had adverse events that required adjustment of the valve programming.Per the article: ¿results: thirty-seven children (19 boys, 18 girls) were identified.Within the first month after shunt placement, a total of 10 patients (27%) developed complications including infections, hygromas, and shunt dysfunction.Shunt survival varied from 1 week to 145 months.Over the 10-year follow-up period, 13 children had their shunts replaced, six of them with a chav without any further complications.A bench test of the cmav was done to test whether the opening pressure was in agreement with the manufacturer¿s specifications.Our results were generally in agreement with specifications stated by the manufacturer.Conclusion: replacing a cmav with a chav was well tolerated by the patients.Bench test results were generally in agreement with manufacturers specifications.Replacing a cmav with a chav in pediatric hydrocephalus patients can be accomplished safely.¿ table 2 describes a single patient who had headache and hyperactivity and had 2 programming adjustments, a single child who had headache and received a single programming adjustment, a single patient who had hygroma formation and had 2 programming adjustments, and a single child who had overdrainage and had 2 programming adjustments.At the time of complaint entry, no device specific information, i.E.Catalogue/lot number, is available.This was discovered via the monthly literature review.
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