BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 2502328 · Received February 21, 2012

    Report

    Report Number
    2916596-2012-00160
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 24, 2012
    Report Date
    January 24, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVAL. NO FURTHER INO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS SUPPORTED WITH A PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) FOR RIGHT VENTRICULAR SUPPORT. THE VAD COORDINATOR REPORTED THAT AFTER TWO WEEKS OF SUPPORT, THE HOSP STAFF COULD NOT GET A SIGNAL ON THE DUAL DRIVE CONSOLE (DDC). THE ELECTRICAL LEADS AND THE DDC WERE REPORTEDLY SWITCHED OUT WITH NO RESOLUTION TO THE ISSUE. THE SURGEON MADE A DECISION TO EXCHANGE THE PVAD WITH A CENTRIMAG RVAD. THE RVAD WAS SUCCESSFULLY EXCHANGED AND THE PT CONTINUES ON RIGHT VENTRICULAR SUPPORT WITHOUT ANY FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM DSQ: VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000 107378

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention