BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOJET ULTRA SYSTEM

    MDR report key: 1410734 · Received June 30, 2009

    Report

    Report Number
    1410734
    Event Type
    Injury
    Date Received
    June 30, 2009
    Date of Event
    June 15, 2009
    Report Date
    June 18, 2009
    Manufacturer
    POSSIS MED, INC.
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UNDERGOING THROMBOLYSIS OF LEFT ARM DIALYSIS SHUNT, PT EXPERIENCED BRADYCARDIA REQUIRING PLACEMENT OF TEMPORARY PACEMAKER. APPROXIMATELY TWO HOURS LATER, WHILE IN ICU, THE PACEMAKER WAS NO LONGER CAPTURING AND THE PT EXPERIENCED BRADYCARDIA AGAIN NECESSITATING RESUSCITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET ULTRA SYSTEM THROMBECTOMY SYSTEM MCX POSSIS MED, INC. 5000A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R