CSF-VENTRICULAR RESERVOIR

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 VENTRICULAR RESERVOIR. IT WAS REPORTED THAT THE MATERIAL WAS OPENED FROM A STERILE, UNOPENED PACKAGE PRIOR TO THE SURGICAL PROCEDURE. AFTER OPENING, A DEFECT WAS OBSERVED ON THE CATHETER OF THE PRODUCT, WHERE A BREAKAGE/FRACTURE WAS IDENTIFIED; THEREFORE, THE PRODUCT WAS NOT USED ON THE PATIENT. NO PATIENT HARM OR IMPACT OCCURRED. TO ENSURE CONTINUITY OF THE PROCEDURE, A REPLACEMENT PRODUCT OF THE SAME TYPE WAS REQUESTED AND USED INSTEAD.