BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LITHOSTAR MODULARIS

    MDR report key: 2862597 · Received December 10, 2012

    Report

    Report Number
    2240869-2012-10484
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    SIEMENS AG
    Product Code
    MMZ
    PMA / PMN Number
    K033335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEMS WAS CHECKED BY SIEMENS LOCAL SERVICE ENGINEER, (B)(6). THE UNIT WAS FOUND TO BE WITHIN SPECIFICATIONS. SELECTION OF ADEQUATE THERAPY PARAMETERS IS THE RESPONSIBILITY OF THE OPERATOR, AND IS DEPENDENT ON THE PATIENT'S CONDITION AND STATE OF HEALTH. CONTRADICTIONS AND ENERGY LEVELS ARE DESCRIBED IN THE OPERATOR MANUAL FOR LITHOSTAR MODULARIS SYSTEM (B)(4). MEDICAL PUBLICATIONS STATE THAT KIDNEY HEMATOMA IS A POSSIBLE ADVERSE EFFECT OF ESWL THERAPY. IT IS NOT SYSTEM SPECIFIC, BUT IS ESWL APPLICATION SPECIFIC.

    Description of Event or Problem · 1

    SIEMENS WAS INFORMED THAT THREE TO FOUR PATIENTS WHO WERE TREATED ON THE LITHOSTAR MODULARIS SYSTEM DEVELOPED HEMATOMA OF THE KIDNEY AFTER ESWL TREATMENTS. THE PATIENTS WERE TREATED BY DIFFERENT OPERATORS ON THE UNIT IN (B)(6) 2012. ACCORDING TO SIEMENS LOCAL SERVICE, THE PATIENTS WERE HOSPITALIZED AFTER TREATMENTS. INFORMATION REGARDING THEIR TREATMENTS OR CONDITIONS WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHOSTAR MODULARIS UROLOGICAL TABLE AND ACCESSORIES MMZ SIEMENS AG 01159107

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O