VENTRICLEAR¿

Additional Manufacturer Narrative

B3 UPDATED 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

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 AN EXTERNAL VENTRICULAR DRAINAGE (EVD) CATHETER. IT WAS REPORTED THAT THE VENTRICULOSTOMY C ATHETER BROKE WHILE THE NURSE WAS TRYING TO ADJUST THE CATHETER/BANDAGE, AND THE PATIENT SCREAMED IN PAIN AND WHACKED THEIR HAND INTO THE PATIENT'S CAUSING THE ORANGE CATHETER ITSELF TO BREAK ROUGHLY 2-3 CM FROM WHERE IT EXITED THE SCALP. THE NURSE WAS ABLE TO CLAMP THE VENTRICULOSTOMY IMMEDIATELY. THEY PHYSICIAN WAS CALLED BY ANOTHER DOCTOR TO REINSERT THE TUBING. THEY DID SHAVE THE PATIENT'S HEAD A BIT MORE TO ACCESS AND ADEQUATELY SECURE THE TUBING. THE BROKEN PORTION OF THE ORANGE CATHETER WAS REMOVED. THE REMAINING STUMP OF THE ORANGE CATHETER AS WELL AS THE CONICAL HUB WERE BOTH PREPPED WITH CLOROPREP PRIOR TO REATTACHING THOSE TWO COMPONENTS. TUBING WAS SECURED. WAVEFORM RETURNED TO BASELINE.