BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3830720 · Received May 6, 2014

    Report

    Report Number
    2916596-2014-00721
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    March 23, 2014
    Report Date
    April 7, 2014
    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 INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENT OF GI BLEEDING COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE INSTRUCTIONS FOR USE LISTS BLEEDING AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    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 FOUND TO HAVE A GL BLEED, AND NO SOURCE OF THE GI BLEED WAS NOTED. AN OUTPATIENT CAPSULE ENDOSCOPY WAS CONDUCTED AND THE RESULTS INCONCLUSIVE. THE PT REMAINS ONGOING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION:IT WAS REPORTED THAT THE PATIENT HAS HAD NO FURTHER ISSUES WITH GI BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270708 HEARTMATE II LVAS LEFT VENTRICULR ASSIST DEVICE DSQ THORATEC CORP. 104911 74332

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention