BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3060406 · Received April 11, 2013

    Report

    Report Number
    2916596-2013-00433
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING THE ACQUIRE THE DEVICE FOR 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 CLINICAL ENGINEER REPORTED THAT THE PERC-LOCK ON THE PT'S SYSTEM CONTROLLER WOULD NOT STAY CLOSED. THE HOSPITAL TRIED ATTACHING THE DRIVELINE OF THEIR MOCK LOOP TO THIS PARTICULAR SYSTEM CONTROLLER AND THE PERC-LOCK WOULD NOT STAY CLOSED. THE PT'S SYSTEM CONTROLLER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156638 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 109010

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other