EDM 27637 VCATH TRANS OD 4.9MM W/TROC

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THE INTERFACE BETWEEN THE VENTRICULAR DRAINAGE TUBE AND THE DRAINAGE BAG WAS LOOSE. UNDER GENERAL ANESTHESIA, THE PATIENT UNDERWENT 1. INTRACEREBRAL HEMATOMA EVACUATION, 2. SKULL DRILLING AND DRAINAGE, 3. SUBTEMPORAL DECOMPRESSION, 4. VENTRICULAR SHUNT, WITH INDWELLING VENTRICULAR DRAINAGE TUBE. ON 04-03, A CT EXAMINATION WAS PERFORMED AROUND 10:00. DURING THE EXAMINATION IN THE CT ROOM,THE VENTRICULAR DRAINAGE TUBE AND DRAINAGE DEVICE FELL OFF. THE CAUSE OF THE EVENT WAS REPORTED THE DRAINAGE TUBE CONNECTOR WAS NOT SECURE. THE PATIENT WAS RETURNED TO THE INTENSIVE CARE UNIT IMMEDIATELY, AND THE VENTRICULAR DRAINAGE TUBE WAS CLAMPED WITH HEMOSTATIC FORCEPS. THE PATIENT'S VITAL SIGNS, CONSCIOUSNESS, AND PUPILS WERE OBSERVED. AFTER INFORMING THE DOCTOR, THE VENTRICULAR DRAINAGE TUBE WAS REMOVED, AND THEN THE LUMBAR DRAINAGE TUBE WAS INDWELLED.

Additional Manufacturer Narrative

MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.