HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER

Additional Manufacturer Narrative

A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION. ADDITIONAL PRODUCTS: CONTROLLER. D4: SERIAL OR LOT#: UNKNOWN. H3: YES. H6: THE CODES PRESENT IN SECTION. H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. PRODUCT EVENT SUMMARY: TWO (2) CONTROLLERS WITH UNKNOWN SERIAL NUMBERS WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS COULD NOT BE PERFORMED SINCE LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. THERE WAS INSUFFICIENT INFORMATION REGARDING THE REPORTED ALARM EVENT. AS A RESULT, THE REPORTED LOSS OF POWER AND ALARM EVENTS COULD NOT BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES, AS DESCRIBED IN THE EVENT DETAILS. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. 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.

Additional Manufacturer Narrative

INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER   D9: NO DEV RTN TO MFR? YES  H5: NO  H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. 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

IT WAS REPORTED BY THE VAD PATIENT DURING A PATIENT ADVISORY MEETING THAT THEY HAD DISCONNECTED BOTH POWER SOURCES FROM THE CONTROLLER, THAT THEY EXPERIENCED ANXIETY WHEN THE CONTROLLER ALARM GOES OFF AND THAT THEY EXCHANGED THEIR CONTROLLER AT HOME AND HEARD ALARMS AFTERWARD. ONE CONTROLLER WAS EXCHANGED AND ONE CONTROLLER REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT