BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2944976 · Received February 1, 2013

    Report

    Report Number
    2916596-2013-00106
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON GOING WITH THE IMPLANTED DEVICE. NO FURTHER INFORMATION 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. IT WAS REPORTED THAT THE PT HAD A RED HEART ALARM AND THE PUMP STOPPED. THE PT EXCHANGED TO BATTERIES. THE POWER MODULE WAS REPLACED AND THE SYSTEM FUNCTIONED NORMALLY. THE POWER MODULE WAS RETURNED TO THE MFR FOR INVESTIGATION, AND THE UNIT WAS FUNCTIONING AS INTENDED FOR SEVERAL DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44678 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 114702

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention