BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3911686 · Received May 28, 2014

    Report

    Report Number
    2916596-2014-00851
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 28, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PT. 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 (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT A FEW MONTHS AFTER IMPLANT THE PT'S LDH INCREASED FROM THE 600'S TO THE 2100'S. THE PT HAS BEEN THERAPEUTIC ON HIS INR WITH HIS GOAL 2.5-3.5 AND A FULL DOSE OF ASPIRIN. THE PATIENT WAS RECENTLY GIVEN PERSANTINE AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314554 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 134684

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention