BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 3082310 · Received April 4, 2013

    Report

    Report Number
    2916596-2013-00388
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    July 25, 2007
    Report Date
    March 8, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURER'S DEVICE TRACKING RECORDS INDICATED THAT THE PATIENT HAD BEEN SUCCESSFULLY TRANSPLANTED AFTER 1.5 MONTHS OF SUPPORT. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE ADDITIONAL INFORMATION FROM THE HOSPITAL REGARDING THIS EVENT. THE ATTACHED USER FACILITY REPORT #(B)(4) WAS RECEIVED FROM THE INTERMACS REGISTRY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH TWO PARACORPOREAL VENTRICULAR ASSIST DEVICES (PVADS) FOR BIVENTRICULAR SUPPORT. THE MANUFACTURER RECEIVED A USER FACILITY REPORT FROM THE INTERMACS REGISTRY STATING THAT THE PATIENT'S RVAD SUPPORTING THE RIGHT VENTRICLE WAS ALARMING WITH LOW FLOW. THERE WERE REPORTEDLY MULTIPLE ALARMS NOTED DAYS PRECEDING THE EVENT. NO OTHER INFORMATION REGARDING THIS EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139566 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM DSQ: VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000 59059

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other