BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3030317 · Received March 28, 2013

    Report

    Report Number
    2916596-2013-00336
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS PRESENTED WITH A PUMP POCKET INFECTION. THE PT WAS RETURNED TO THE OPERATING ROOM WHERE WOUND VAC AND DRAINS WERE PLACED IN THE PUMP POCKET. THE PT IS BEING TREATED WITH IV ANTIBIOTICS. THERE ARE NO ISSUES WITH THE LVAD PUMP, ALTHOUGH A PUMP EXCHANGE HAS BEEN CONSIDERED. PT IS CURRENTLY LISTED AS STATUS 1A FOR HEART TRANSPLANT. PT IS UP WALKING AROUND AND IS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130011 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 118680

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention