BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II

    MDR report key: 10028363 · Received May 6, 2020

    Report

    Report Number
    10028363
    Event Type
    Injury
    Date Received
    May 6, 2020
    Date of Event
    March 24, 2019
    Report Date
    April 28, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEARTMATE II PRESENTS WITH TRAUMATIC SUBARACHNOID HEMORRHAGE (SAH) IN THE SETTING OF SUPRATHERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR) 5.0 AND STREPTOCOCCAL BACTEREMIA. INR WAS REVERSED WITH PLASMA AND VITAMIN K; NO SURGICAL INTERVENTION WAS REQUIRED FOR THE SAH. HEPARIN WAS RESUMED, AND HEPARIN BRIDGE TO COUMADIN WAS COMPLETED PRIOR TO DISCHARGE. ASPIRIN 81 MG THREE TIMES WEEKLY WAS RESUMED. BACTEREMIA WAS MANAGED WITH IV ANTIBIOTICS X 4 WEEKS AFTER DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494494 HEARTMATE II VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA Hospitalization| L| S