VENTRICLEAR¿

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT ON AUGUST 11, 2025, SUBSTANTIAL DRAINAGE WAS ON THE PILLOW FROM EXTERNAL VENTRICULAR DRAIN (EVD). THE DOCTOR CAME TO THE BEDSIDE TO EXAMINE THE PATIENT AND WAS INFORMED OF THE DRAINAGE. THEY EXAMINED, CHANGED DRESSING AND ADDED GAUZE BUT NO LEAKING NOTED AT INSERTION SITE. THE PATIENT BEGAN TO COUGH, AND THE MANUFACTURER REPRESENTATIVE NOTED DRAINAGE FROM THE TUBING AND SHOWED THE PROVIDER. THE LEAK WAS IN THE CATHETER OUTSIDE OF THE PATIENT BEFORE THE CONNECTION TO THE EVD. PROVIDER CONSULTED OTHER PROVIDERS AND CATHETER WAS CUT ABOVE LEAK AND SYSTEM WAS EXCHANGED. TUBING WAS SAVED AND GIVEN TO LEADERSHIP. IT WAS NOTED THAT THE CATHETER AND EVD WERE PLACED IN SURGERY ON (B)(6) 2025. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

Additional Manufacturer Narrative

H3. PRODUCT ANALYSIS DETERMINED THAT THE VISUAL AND FUNCTIONAL INSPECTION CONFIRMED THE RETURNED PORTION OF THE CATHETER DID NOT LEAK WHEN TESTED. THE PORTED END OF THE CATHETER HAD BEEN CUT OFF AND NOT RETURNED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.