Description of Event or Problem · 0
A 69 Y.O. F WITH A PMH OF L3-L5 SEVERE STENOSIS, HTN, HLD, DEPRESSION WHO PRESENTED TO (B)(6) ON (B)(6) 26 WITH SEIZURE LIKE ACTIVITY. SHE WAS RECENTLY ADMITTED TO (B)(6) HOSPITAL FOR ELECTIVE PROCEDURE OF LUMBAR FUSION AND HAD 2 EPISODES OF SEIZURE ACTIVITY POST-OPERATIVELY. SHE WAS INTUBATED AND STARTED ON PROPOFOL AND KEPPRA 1G BID (AFTER A 4G LOAD) AND TRANSFERRED TO (B)(6) FOR FURTHER MANAGEMENT. SHE WAS INITIALLY ADMITTED TO THE NCCU ON (B)(6), EXTUBATED ON (B)(6) AND TRANSFERRED TO NEUROLOGY SERVICE (B)(6). THERE WAS INITIAL CONCERN FOR PRES VS CVST ON CT IMAGING, NO CONCERN FOR EITHER OF THESE ON FURTHER TESTING. MRI BRAIN WITH PACHYMENINGEAL ENHANCEMENT AND MRI SPINE WITH EVIDENCE OF POSSIBLE CSF LEAK SECONDARY TO THE RECENT SURGERY. NSGY WAS CONSULTED AND HAD LOW SUSPICION FOR CSF LEAK AT THIS TIME. PATIENT CONTINUES TO HAVE DYSPHAGIA AND DYSPHONIA SINCE EXTUBATION, SLP WORKING WITH PATIENT, CONTINUES TO BE NPO AT THIS TIME WITH TUBE FEEDS. ENT CONSULTED, STARTED ON DEXAMETHASONE TO HELP WITH LARYNGEAL EDEMA. MRI ORDERED TO EVALUATE FOR OTHER CAUSES OF DYSPHAGIA. 3/25 BRAIN MRI REVEALED SMALL FOCI OF ACUTE INFARCTS IN THE RIGHT INSULA AND RIGHT EXTERNAL CAPSULE, NEW SINCE PRIOR MRI. INCREASED SIZE OF THIN BILATERAL CEREBRAL CONVEXITY SUBDURAL COLLECTION, SLITLIKE APPEARANCE OF THE VENTRICLES, WHICH CAN BE SEEN IN THE SETTING OF INTRACRANIAL HYPOTENSION. NEURO STROKE WAS CONSULTED. THEY RECOMMENDED TO KEEP MEDS THE SAME AND ORDERED A TTE. SLP ORDERED MBSS AND IT REVEALED INCONSISTENT CLEARANCE WITH ASPIRATION. PEG TUBE PLACED ON (B)(6). THE PATIENT DEVELOPED SEIZURE POST PROCEDURE. THE CASE DID HAVE BLOOD LOSS AND A FAIR AMOUNT OF NEURO SPONGES WERE USED IN THE CASE. THESE ARE THE SAME SPONGES NOTED IN THE 3/18 MEDLINE RECALL. MEDLINE INDUSTRIES, LP IS ISSUING A RECALL FOR SPECIFIC ITEM(S) AND LOT(S) OF MEDLINE NEURO SPONGES. DURING AN INTERNAL REVIEW, MEDLINE IDENTIFIED HIGHER-THAN EXPECTED ENDOTOXIN LEVELS ON A REPRESENTATIVE MEDLINE NEURO SPONGE PRODUCT, INDICATING THAT IN-MARKET PRODUCT MAY BE OUT-OF SPECIFICATION FOR ENDOTOXIN. ELEVATED ENDOTOXIN LEVELS MAY PRESENT POTENTIAL HEALTH RISKS THAT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION, SUCH AS NEUROVASCULAR ADVERSE EVENTS, FEBRILE RESPONSE, AND/OR LOCAL TRANSIENT INFLAMMATION, HYPOTENSION, OR NAUSEA. OUT OF AN ABUNDANCE OF CAUTION, DUE TO THE UNEXPLAINED NATURE OF THE SEIZURE AND THE POTENTIAL ENDOTOXIN PRESENCE ON THE SPONGE, THE PATIENT WILL BE NOTIFIED AND FDA ONLINE VOLUNTARY REPORTING FORM COMPLETED.