BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT DELTA LITHOTRIPTER UNIT 424

    MDR report key: 1025518 · Received March 20, 2008

    Report

    Report Number
    1025518
    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 ADMITTED FOR LITHOTRIPSY. PT HAS A 1.2 CM KIDNEY STONE CLOSE TO THE RENAL PELVIS. THE PATIENT WAS ADVISED TO HAVE AN ESWL. THE PATIENT WAS BROUGHT TO THE LITHOTRIPSY SUITE, PLACED ON THE LITHOTRIPTOR TABLE AND SHE WAS GIVEN A GENERAL ANESTHESIA. THE STONE WAS BROUGHT INTO THE CROSS HAIRS OF THE MONITOR ON BOTH PROJECTIONS. THE PATIENT WAS THEN PROPERLY COUPLED TO THE LITHOTRIPSY HEAD. A TOTAL OF 2500 SHOCKS WERE DELIVERED TO THE STONE WITH MINIMAL FRAGMENTATION OF THE STONE. AT THE END OF THE PROCEDURE, THE PATIENT WAS RETURNED TO THE POSTANESTHESIA ROOM IN A SATISFACTORY CONDITION. CONCLUSION: MINIMAL FRAGMENTATION OF THE STONE BY ESWL. LATER IN RECOVERY THE PATIENT BEGAN TO HAVE INCREASED PAIN. THE PATIENT WAS TRANSFERRED TO A LOCAL HOSPITAL AND IT WAS DETERMINED THAT SHE HAD A HEMATOMA ON HER KIDNEY.

    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 59 YR Hospitalization| R