BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2431320 · Received January 24, 2012

    Report

    Report Number
    2916596-2012-00011
    Event Type
    Injury
    Date Received
    January 24, 2012
    Date of Event
    December 28, 2011
    Report Date
    December 28, 2011
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFO 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT EXPERIENCED ALARMS AND PUMP STOPPAGES. IT WAS REPORTED THAT THE PT WAS READMITTED WITH SIGNS OF CONGESTIVE HEART FAILURE AND A SUSPECTED PUMP CLOT. A DECISION WAS MADE TO TURN OFF THE PUMP AND THERE IS NO CURRENT PLANS FOR A PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP 103695 102430

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention