BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4122419 · Received September 18, 2014

    Report

    Report Number
    2916596-2014-01646
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    April 4, 2014
    Report Date
    August 20, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 10 MONTHS AND 5 DAYS. A SPECIFIC CAUSE FOR THE REPORTED GI BLEED COULD NOT BE DETERMINED THROUGH THIS EVALUATION AS THE PATIENT REMAINS ONGOING ON LVAD SUPPORT. NO FURTHER RELATED EVENTS HAVE BEEN REPORTED. 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.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT HAD A COLONOSCOPY AND POLYPS WERE REMOVED. THE PATIENT HAD GI BLEEDING RELATED TO POLYPECTOMY. THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF PACKED RED BLOOD CELLS, AND THE SOURCE OF THE BLEEDING WAS CLIPPED. IT WAS ALSO REPORTED THAT IT WAS NOT PUMP RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579254 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 126843

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention