Description of Event or Problem · 0
(LNTEGRA LIFE SCIENCES RICKHAM RESERVOIR 6 MM; MODEL 82-1621) LOT NUMBER 5677259. UDI NUMBER (B)(4). CLOBAZAM, MIDAZOLAM HYDROCHLORIDE, CLONAZEPAM, ONDANSETRON, AND MELATONIN,ASCORBIC ACID/CYANOCOBALAMIN/ERGOCALCIFEROL/FOLIC ACID/LRON/NICOTINAMIDE/PYRIDOXINE HYDROCHLORIDE/RETINAL/RIBOFLAVIN/THIAMINE HYDROCHLORIDE/TOCOPHEROL. PREMEDICATION USED FOR THE SUBJECT'S BRINEURA INFUSIONS INCLUDED CETIRIZINE HYDROCHLORIDE AND PARACETAMOL. ON (B)(6) 2019, THE SUBJECT UNDERWENT IMPLANTATION OF INTRACEREBRAL VENTRICULOSTOMY (ICV) SET (LNTEGRA LIFE SCIENCES RICKHAM RESERVOIR 6 MM; MODEL 82-1621) LOT NUMBER 5677259. UDI NUMBER (B)(6). ON (B)(6) 2021, THE SUBJECT INITIATED TREATMENT WITH BRINEURA (300 MILLIGRAM, QOW, INTRACEREBROVENTRICULAR USE). THE LOT NUMBER FOR BRINEURA WAS NOT REPORTED. THE MOST RECENT DOSE WAS ADMINISTERED ON (B)(6) 2021. ON (B)(6) 2022, THE SUBJECT WAS HOSPITALIZED FOR A PROPHYLACTIC INTRAVENTRICULAR DEVICE REPLACEMENT (DEVICE END OF SERVICE). THE INTENSITY OF THE EVENT WAS REPORTED AS GRADE 3. THE SURGERY WENT AS PLANNED WITH NO COMPLICATIONS. NO LABORATORY OR DIAGNOSTIC TESTS WERE REPORTED. NO ADDITIONAL TREATMENT FOR THE EVENT WAS REPORTED. NO ACTION WAS TAKEN WITH BRINEURA DUE TO THE EVENT. THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERING/RESOLVING. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE END OF SERVICE AS NOT RELATED TO TREATMENT WITH BRINEURA. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE END OF SERVICE AS RELATED TO THE ICV DEVICE. OTHER POSSIBLE ETIOLOGICAL FACTORS INCLUDED THE DEVICE END OF LIFE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND, IF RECEIVED, THE REPORT WILL BE UPDATED. CASE COMMENT: ICV DEVICE WAS PROPHYLACTICALLY REPLACED DUE TO END OF LIFE CYCLE OF DEVICE. IT IS USUALLY DUE TO MATERIAL DEGRADATION OF DEVICE BECAUSE OF LONG PERIODS OF USE. THE CAUSALITY OF EVENT IS ASSESSED AS NOT RELATED TO BRINEURA. 605158111. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).