BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4439675 · Received January 22, 2015

    Report

    Report Number
    2916596-2015-00143
    Event Type
    Injury
    Date Received
    January 22, 2015
    Date of Event
    November 17, 2014
    Report Date
    December 26, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE FOR THE PATIENT¿S GI BLEED COULD NOT BE DETERMINED. IT WAS COMMUNICATED THAT THE PATIENT EXPERIENCED A GI BLEED. THE CENTER REDUCED ANTICOAGULATION AND CONTINUED TO MONITOR THE PATIENT. NO ALARMS WERE REPORTED AND THE PATIENT HAS BEEN DISCHARGED HOME. FURTHERMORE, THE PATIENT REMAINS ONGOING ON VAD SUPPORT AND NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED AT THIS TIME. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE IS 6 MONTHS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR GI BLEEDING. ANTICOAGULATION WAS REDUCED. THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52282 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention