BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3032467 · Received March 29, 2013

    Report

    Report Number
    2916596-2013-00347
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 1, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PT. 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 (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS ADMITTED INTO THE HOSPITAL FOR CONGESTIVE HEART FAILURE (CHF). THE PT WAS HAVING LEG CRAMPS AND DECIDED TO DECREASE HER LASIX FROM 80 BID TO 40 BID ON HER OWN FOR TWO WEEKS. THE PT WENT INTO THE CLINIC IN CHF EXACERBATION. THE PT WAS DIURESED WITH LASIX, PLACED ON FLUID RESTRICTION, AND ALSO ADMINISTERED MEDICATION. THE PT WAS DISCHARGED 5 DAYS LATER. THE VAD COORDINATOR REPORTED THAT THE PT IS DOING WELL WITH NO FURTHER ISSUES WITH CHF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129898 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 107102

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention