BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS

    MDR report key: 3151818 · Received June 3, 2013

    Report

    Report Number
    MW5030454
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 23, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ANGIODYNAMIC POWER PORT IMPLANTED FOR 3 YEARS WAS USED AS USUAL TO INFUSE MEDICATION FOR MS. THE DEVICE WOULD NOT RESPOND OR ALLOW FOR THE INFUSION TO OCCUR AND SEVERE CHEST PAIN ENSUED. PT WENT TO THE EMERGENCY ROOM AND WAS RUSHED TO SURGERY AFTER X-RAYS CONCLUDED THAT THE DEVICE BROKE APART IN SEVERAL PLACES. PARK OF THE DEVICE RESTED ON THE HEART AND HAD BEGUN TO GROW 20 GRAMS OF RESISTANT STAPH WHICH HAD SPREAD SYSTEMIC. THE HEART RESPONDED BY DEVELOPING SEVERE ENDOCARDITIS. THE PT HAS REMAINED IN THE HOSPITAL FOR THE PAST 50 DAYS RECEIVING VARIOUS ANTIBIOTICS TO RESOLVE THE RAGING INFECTION. PT HAS PROGRESSIVE MS AND WAS...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242608 ANGIODYNAMICS POWERPORT LJT ANGIODYNAMICS 520279

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R| S