BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT DELTA LITHOTRIPTER UNIT 424

    MDR report key: 1025964 · Received March 20, 2008

    Report

    Report Number
    1025964
    Event Type
    Injury
    Date Received
    March 20, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 20, 2008
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    NCV
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED FOR LEFT EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY AND INTRAOPERATIVE FLUOROSCOPY AND SONOGRAPHY. A TOTAL OF 2500 SHOCK WAVES WERE DELIVERED AT A POWER OF FIVE TO THE RENAL CALCULUS. PT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM. WHILE IN RECOVERY THE PT STARTED TO FEEL NAUSEATED AND FAINT. HER BP AND HGB BEGAN TO DROP. THE PATIENT WAS THEN TRANSFERRED TO THE MAIN HOSPITAL. A CT SHOWED A GRADE 2-3 SPLENIC INJURY AND A SMALL LACERATION TO THE POSTERIOR ASPECT OF THE KIDNEY. PT WAS ADMITTED TO THE ICU AWAKE AND RESPONSIVE. PT IS CURRENTLY RECEIVING BLOOD TRANSFUSIONS. PT HAD A 7-8 MM CALCULUS. PT WAS COUPLED TO THE LITHOTRIPTOR MACHINE AND THE STONE WAS LOCALIZED IN THE ANTERIOR, POSTERIOR AS WELL AS IN THE CRANIOCAUDAL ORIENTATIONS. SHOCK WAVES WERE BEGUN DELIVERED AT LOW ENERGY AND NO ECTOPY WAS SEEN ON KUB. SERIAL FLUOROSCOPY AND SONOGRAPHY CONFIRMED CONTINUED LOCALIZATION OF THE STONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT DELTA LITHOTRIPTER UNIT 424 LITHOTRIPTER NCV DORNIER MEDTECH AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R NO OTHER THERAPIES| NO OTHER THERAPIES