CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS INLINE VLV W/UNTZD CAT; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
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Catalog Number 82-8802 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Neurological Deficit/Dysfunction (1982)
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Event Date 03/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) 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, 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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Event Description
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It was reported by the ous affiliate that certus plus valve migrated/inverted after implantation, the valve was unable to be programmed and that the patient suffered neurologic deficits associated to this event.The valve was implanted to the patient via lp-shunt with setting 4 due to normal pressure hydrocephalus.It was reported that when checking the shunt under fluoroscopy, the inversion of the valve was confirmed.Recently, walking disturbance occurred, so the physician attempted to adjust the programming to 3, but adjustment was unsuccessful secondary to the valve inversion.The valve adjusted slightly, and may be at setting 7.The device remains implanted and the patient is being monitored.The surgeon plans to attempt programming again with the tool kit and neodymium under fluoroscopy.No further information was provided by hospital.The product will not be returned to your site.
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