BEUDAMED
    FDA Adverse Event Other Summary report: N

    YNCARDIA COMPANION 2 DRIVER

    MDR report key: 3423421 · Received August 30, 2013

    Report

    Report Number
    3003761017-2013-00100
    Event Type
    Other
    Date Received
    August 30, 2013
    Date of Event
    August 7, 2013
    Report Date
    August 29, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER SUPPORTING A PATIENT IS EXHIBITING A NON-TYPICAL RIGHT WAVEFORM, WITH A SHARP INCLINE PRIOR TO THE OPENING OF THE TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) VALVE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT IS DOING VERY WELL AND THEY DO NOT PLAN TO SWITCH THE PATIENT TO ANOTHER DRIVER AT THIS TIME. SYNCARDIA INVESTIGATED ANOTHER COMPANION 2 DRIVER THAT EXHIBITED A SIMILAR NON-TYPICAL WAVEFORM. TESTING DETERMINED THAT THE ROOT CAUSE FO THE NON-TYPICAL SHAPE OF THE WAVEFORM WAS THE RIGHT ELECTRONIC PRESSURE REGULATOR. IN SPITE OF THE NON-TYPICAL SHAPE OF THE WAVEFORM, ALL OF THE MEASURED PARAMETERS TO ASSURE SAFE SUPPORT OF THE PATIENT WERE NORMAL. THE REPORTED ISSUE POSES A LOW RISK TO THE PATIENT BECAUSE IT DOES NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431104 YNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR