BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LITHOSTAR MODULARIS

    MDR report key: 1558371 · Received December 11, 2009

    Report

    Report Number
    2240869-2009-00040
    Event Type
    Injury
    Date Received
    December 11, 2009
    Date of Event
    October 5, 2009
    Report Date
    December 8, 2009
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    MMZ
    PMA / PMN Number
    K033335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE CUSTOMER, APPROXIMATELY 75 PATIENTS WERE TREATED SINCE THE EVENT, WITH NO NOTICABLE PROBLEMS ENCOUNTERED. THE PATIENT'S STONE WAS PREVIOUSLY TREATED IN 2009, AT THE RIGHT UPJ WITH 4000 SHOCKS AT 4.0 POWER LEVEL, 3.4 POWER LEVEL AVERAGE WITH TOTAL ENERGY OF 185.25 WITH POOR RESULTS. BECAUSE OF THIS AND OTHER POOR RESULTS, STEPS WERE INITIATED TO DETERMINE THE EFFECTIVENESS OF THE SHOCK HEAD. THE SHOCK HEAD WAS REPLACED JUST PRIOR TO THE PATIENT'S SECOND TREATMENT THE FOLLOWING MONTH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMMEDIATELY FOLLOWING A LITHOTRIPSY PROCEDURE, A MALE PATIENT DEVELOPED A PERFORATED BOWEL WHICH REQUIRED SURGICAL CORRECTION (SMALL BOWEL RESECTION), PERFORMED BY MD. THE LITHOTRIPSY TREATMENT WAS FOR A 7X8 MM STONE IN THE RIGHT MID-URETER. SERVICE CHECKED THE UNIT, AND NO CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE COULD BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHOSTAR MODULARIS TABLE, CYSTOMETRIC, ELECTRIC MMZ SIEMENS MEDICAL SOLUTIONS USA, INC. 05531103 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention