MEDLINE

Additional Manufacturer Narrative

DISCREPANCIES NOTED REGARDING PATIENT WEIGHT: MEDWATCH (MW5186400) REPORTED 111 KG. FACILITY REPORTED 199 LBS.

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY, ON (B)(6) 2026, THE PATIENT UNDERWENT AN L2-S1 DECOMPRESSION AND FUSION WITH L3-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION USING O ARM. THE SURGERY CUT TIME WAS REPORTED AS 0846, WITH A SURGERY STOP TIME OF 1636. DURING THE PROCEDURE, SPONGE SURG 0.5 X 0.5 IN RADIOPAQUE STRING CONTAINING COTTON NEUROPATTIES (NEUROSPNG05) WERE USED, WITH ONE PACK OPENED ON THE FIELD. ADDITIONALLY, SPONGE SURG 3 X 0.5 IN FLEXIBLE STRING CONTAINING RADIOPAQUE COTTON FIBER SPONGES (NEUROSPNG09) WERE USED, WITH THREE PACKS OPENED ON THE FIELD. THE FACILITY REPORTED THAT "UNSURE EXACT NUMBER OF PATTIES [SURGEON] USED." POST OPERATIVELY, THE PATIENT REPORTEDLY "HAD 2 EPISODES OF SEIZURE ACTIVITY POST-OPERATIVELY." THE PATIENT WAS "INTUBATED AND STARTED ON PROPOFOL AND KEPPRA 1G BID (AFTER A 4G LOAD)" AND "TRANSFERRED FOR FURTHER MANAGEMENT." THE PATIENT WAS "INITIALLY ADMITTED TO THE (B)(6) ON (B)(6) 2026, 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 FINDINGS INCLUDED "PACHYMENINGEAL ENHANCEMENT" AND "POSSIBLE CSF LEAK SECONDARY TO THE RECENT SURGERY," WITH "LOW SUSPICION FOR CSF LEAK." THE PATIENT "REMAINED HYPERTENSIVE THROUGHOUT ADMISSION" AND WAS "TRANSFERRED TO MEDICINE SERVICE ON (B)(6)." THE PATIENT "DEVELOPED DYSPHAGIA AND DYSPHONIA SINCE EXTUBATION" AND "CONTINUES TO BE NPO WITH TUBE FEEDS." ENT WAS CONSULTED AND THE PATIENT WAS "STARTED ON DEXAMETHASONE TO HELP WITH LARYNGEAL EDEMA." A BRAIN MRI ON (B)(6) REVEALED "SMALL FOCI OF ACUTE INFARCTS IN THE RIGHT INSULA AND RIGHT EXTERNAL CAPSULE" AND "INCREASED SIZE OF THIN BILATERAL CEREBRAL CONVEXITY SUBDURAL COLLECTION...WHICH CAN BE SEEN IN THE SETTING OF INTRACRANIAL HYPOTENSION." A MODIFIED BARIUM SWALLOW STUDY "REVEALED INCONSISTENT CLEARANCE WITH ASPIRATION." THE PATIENT "HAS HAD HER NG TUBE SINCE 03/19 AND CANNOT GO TO REHAB WITH IT IN." A PEG TUBE WAS PLACED ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT "STATES THAT SHE IS DOING WELL AFTER HAVING HER NG TUBE REMOVED AND PEG TUBE PLACED." THE PEG SITE WAS "CLEAR WITHOUT EDEMA, ERYTHEMA, OR DISCHARGE." THE PATIENT "DENIES CHEST PAIN, SHORTNESS OF BREATH, OR FEVERS." THE PLAN WAS FOR TRANSFER TO REHABILITATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.

Description of Event or Problem

ACCORDING TO THE FACILITY, ON (B)(6) 2026, THE PATIENT UNDERWENT AN L2-S1 DECOMPRESSION AND FUSION WITH L3-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION USING O ARM. THE SURGERY CUT TIME WAS REPORTED AS 0846, WITH A SURGERY STOP TIME OF 1636. DURING THE PROCEDURE, SPONGE SURG 0.5 X 0.5 IN RADIOPAQUE STRING CONTAINING COTTON NEUROPATTIES (NEUROSPNG05) WERE USED, WITH ONE PACK OPENED ON THE FIELD. ADDITIONALLY, SPONGE SURG 3 X 0.5 IN FLEXIBLE STRING CONTAINING RADIOPAQUE COTTON FIBER SPONGES (NEUROSPNG09) WERE USED, WITH THREE PACKS OPENED ON THE FIELD. THE FACILITY REPORTED THAT "UNSURE EXACT NUMBER OF PATTIES [SURGEON] USED." POST OPERATIVELY, THE PATIENT REPORTEDLY "HAD 2 EPISODES OF SEIZURE ACTIVITY POST-OPERATIVELY." THE PATIENT WAS "INTUBATED AND STARTED ON PROPOFOL AND KEPPRA 1G BID (AFTER A 4G LOAD)" AND "TRANSFERRED FOR FURTHER MANAGEMENT." THE PATIENT WAS "INITIALLY ADMITTED TO THE NCCU ON (B)(6) 2026, EXTUBATED ON (B)(6), AND TRANSFERRED TO NEUROLOGY SERVICE (B)(6)."