MEDRONIC EXTERNAL MONITORING FOR CSF
Received Apr 10, 2024 · Event occurred Mar 16, 2023
Report MW5153724 · MDR key 19088653
Device
Generic name
External Cerebrospinal Fluid (csf) Diversion
Manufacturer
Medtronic Mexico S. De R.l. De CvPatient
4 YR · Male
- Cerebrospinal Fluid Leakage
- Cerebrospinal Fluid Leakage
Narrative
Description of Event or Problem
MY SON (B)(6) (B)(6) 2018 - WAS HOSPITALIZED AT (B)(6) UNDER THE CARE OF DR. (B)(6), WITH HIGH CSF FOLLOWING A SURGERY. A MEDTRONIC DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM, INTERLINK INJECTION SITES, REF 46913, STERILE EO, RX ONLY. USED TO DRAIN CEREBROSPINAL FLUID (CSF) AS A MEANS TO REDUCE INTRACRANIAL PRESSURE AND CSF VOLUME. - WAS USED TO MONITOR CSF AND PULL OFF CSF AS NECESSARY. ON MULTIPLE OCCASIONS THE STOPCOCK BECAME DISCONNECTED. AS A RESULT SIGNIFICANT AMOUNTS OF CSF WAS DRAINED AND MY SON HAD ADVERSE RESULT. SEE HIS MEDICAL RECORDS. HE HAS TO CALL THE EMERGENCY TEAM AND GO MRI, CT SCAN, EMERGENCY SPINAL TABS AND OTHER ACTIONS. (B)(6).