BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTIRCULAR ASSIST DEVICE

    MDR report key: 3940333 · Received June 19, 2014

    Report

    Report Number
    2916596-2014-00873
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    March 15, 2014
    Report Date
    May 22, 2014
    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 CONTINUES A LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED. 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 HAD A GASTROINTESTINAL (GI) BLEED AND WAS READMITTED. THE PT UNDERWENT A COLONOSCOPY. POLYS WERE FOUND AND CLIPPED. NO REOCCURRENCE OF BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360785 HEARTMATE II LEFT VENTIRCULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 135869

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention