BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECONOLITH 2000 (E2000)

    MDR report key: 505404 · Received January 7, 2004

    Report

    Report Number
    1123459-2003-00002
    Event Type
    Injury
    Date Received
    January 7, 2004
    Date of Event
    November 19, 2003
    Report Date
    December 20, 2003
    Manufacturer
    MEDISPEC, LTD.
    Product Code
    LNS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT AN OUTPATIENT TREATMENT PROCEDURE WITH THE ECONOLITH 2000 ESWL DEVICE. THE PROCEDURE WAS PERFORMED BY A HEALTH PROFESSIONAL TRAINED AND CERTIFIED BY MEDISPEC LTD. THE PROCEDURE WAS REPORTED TO BE ROUTINE WITH NO DEVICE MALFUNCTIONS. THE PT TREATED AND OBSERVED. SHORTLY AFTER THE TREATMENT THE PT EXPERIENCED SHOULDER PAIN. THE PHYSICIANS ADVISED THE PT TO STAY IN THE HOSP AND RECOMMEND THAT PT UNDERGO FURTHER OBSERVATION AND ANALYSIS HOWEVER, THE PT REFUSED AND OPTED TO LEAVE THE HOSP. THE PT WAS THEN DISCHARGED FROM THE FACILITY. EIGHT HOURS POST-TREATMENT THE PT RETURNED TO THE HOSPITAL IN CRITICAL CONDITION AND WAS IN APPARENT SHOCK. PT WAS STABILIZED ANF THEN IMMEDIATELY TAKEN TO THE O.R. WHERE PHYSICIANS DISCOVERED INTRA-ABDOMINAL BLEEDING FROM SPLENIC TRAUMA (RUPTURE). AN EMERGENCY SPLENCTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECONOLITH 2000 (E2000) EXTRACORPOREAL SHOCKWAVE LITHOTRIPTER LNS MEDISPEC, LTD. ECONOLITH DHR# 1.3.2-309 NA
    2 ECONOLITH 2000 (E2000) TREATMENT TABLE LNS MEDISPEC LTD ECONOLITH DHR# 1.3.2-309 NA
    3 ECONOLITH 2000 (E2000) C-ARM LNS MEDISPEC LTD * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization