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Catalog Number UNK VALVE |
Device Problem
Migration (4003)
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Patient Problem
Neurological Deficit/Dysfunction (1982)
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Event Date 10/03/2018 |
Event Type
Injury
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Manufacturer Narrative
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Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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In the literature article ¿intra-ventricular migration of a subcutaneous reservoir after neuroendoscopy¿ by daniela falk & marcus o.Pinsker & h.Maximilian mehdorn & arya nabavi, published childs nerv syst (2017) 33: 2079¿2080, doi 10.1007/s00381-017-3606-8, it was reported that an unknown rickham reservoir migrated after implantation and was revised.Per the article: ¿the placement of a subcutaneous reservoir for primary treatment of different types of hydrocephalus in infants is an effective and safe method.Complications are rare.Intraventricular migration of a reservoir is rare and associated with further surgeries¿ a (b)(6) girl was born via c-section and in the first days of life, a complex brain malformation with hemorrhage, hydrocephalus and separation of the fourth ventricle was diagnosed¿twenty days post-partum, an endoscopic septoventriculostomy was performed¿.A subcutaneous rickham reservoir was placed over the burr hole¿.An mri 2 month after surgery showed accurate placement of the reservoir¿.Four months later, the seizures increased.Ct scan documented a migration of the entire subcutaneous reservoir from the right frontal burr-hole through the posterior part of the lateral ventricle¿.In this specific case, we consider the mechanism to be simpler, even though the diameter of the burr hole was smaller than the base of the rickham, it is most likely that due to the plasticity of the child¿s skull, the counter pressure was not enough.¿ at the time of complaint entry, no device specific information, i.E.Catalogue/lot number, is available.
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Manufacturer Narrative
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Udi: unknown part number, all 3 attempts to obtain product were unsuccessful, udi unavailable.Corrected fields: device available for evaluation.It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman and no product or 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 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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