INNERVISION VENTRICULAR CATHETER, WITHOUT BIOGLIDE, BARIUM IMPREGNATED

Additional Manufacturer Narrative

ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD DEVELOPED A RECURRENT FEVER ABOUT A WEEK AFTER THE PLACEMENT OF THE EXTERNAL VENTRICULAR DRAIN IN THE OPERATING ROOM. AFTER THE CEREBROSPINAL FLUID CULTURE REVEALED THE MYCOBACTERIUM ABSCESSUS, THE EXTERNAL VENTRICULAR DRAIN (EVD) WAS REMOVED AND REPLACED WITH A NEW EVD CATHETER. AFTER THE REPLACEMENT, THE PATIENT REMAINED CLINICALLY STABLE, WITH NO EVIDENCE OF SYSTEMIC INFECTION AND NO NEW FEVERS. IT WAS STATED THAT ALL CULTURES REMAINED NEGATIVE AFTER REPLACING THE EVD CATHETER. REPORTEDLY, THE HOSPITAL¿S INVESTIGATION DID NOT IDENTIFY ANY ENVIRONMENTAL SOURCE OF THE INFECTION. THE PATIENT HAD A MEDICAL HISTORY OF BILATERAL INTRAVENTRICULAR HEMORRHAGE AND HYDROCEPHALUS. ACCORDING TO THE REPORTED INFORMATION, THE EXTERNAL DRAINAGE SYSTEM WAS THE MANUFACTURER¿S PRODUCT AND THE EVD CATHETER WAS A DIFFERENT MANUFACTURER¿S PRODUCT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT A SMALL CATHETER WAS USED. THIS CONNECTED TO A STRAIGHT CONNECTOR WHICH THEN ATTACHED TO A REGULAR EVD CATHETER WITH THE TIP CUT OFF. THIS EVENT HAD BEEN PREVIOUSLY REPORTED UNDER MANUFACTURER REPORT NUMBER 2021898-2016-00470. THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE.

Description of Event or Problem

IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT DEVELOPED AN INFECTION AFTER THE PLACEMENT OF THE DEVICE ON (B)(6) 2016. ACCORDING TO THE REPORT, THE PATIENT FOUND TO HAVE MYCOBACTERIUM CHELONAE-ABSCESSUS GROUP GROWING IN CULTURE FROM CEREBROSPINAL FLUID.

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.