BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3042377 · Received March 15, 2013

    Report

    Report Number
    2916596-2013-00286
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    November 4, 2012
    Report Date
    February 15, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHED USER FACILITY REPORT (B)(4) WAS RECEIVED FROM THE INTERMACS REGISTRY. THE PT CONTINUES ON LVAD SUPPORT. THE MFR IS ATTEMPTING TO ACQUIRE THE PRODUCT FOR FURTHER EVAL. NO FURTHER INFO 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 IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MFR RECEIVED AN (B)(4) REGISTRY REPORT INDICATING THAT WHILE CHANGING THE PT'S BATTERIES, THE PT RECEIVED A RED HEART ALARM AND THE PUMP STOPPED FOR LESS THAN 2 MINUTES. THE PT ALSO HAD A LOW VOLTAGE AND LOW FLOW ADVISORY. THE ENGINEER STATED THE PUMP STOPPAGE WAS DUE TO A FAULTY BATTERY CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110557 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 100858

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other