BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1840470 · Received September 10, 2010

    Report

    Report Number
    1840470
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    September 5, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ABIOMED
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    THE PT HAD AN IMPELLA 5.0 PLACED FOR CARDIOGENIC SHOCK AND ACUTE EXACERBATION OF END-STAGE CARDIOMYOPATHY. THE DEVICE CEASED FUNCTIONING. THE PT WAS EMERGENTLY TAKEN TO THE OPERATING ROOM FOR REPLACEMENT OF A NEW IMPELLA LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * IMPELLA 5.0 KFM ABIOMED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR