BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA RP

    MDR report key: 6431656 · Received March 24, 2017

    Report

    Report Number
    6431656
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    March 2, 2017
    Report Date
    March 8, 2017
    Manufacturer
    ABIOMED, INC.
    Product Code
    OJE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IMPELLA RP DEVICE MALFUNCTIONED PER THE DR. AND THE PRODUCT DEVICE REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214946 IMPELLA RP RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE OJE ABIOMED, INC. 004334

    Patients

    Seq Age Sex Outcome Treatment
    1 NO| NO OTHER THERAPIES