BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDISPEC

    MDR report key: 680690 · Received January 30, 2006

    Report

    Report Number
    680690
    Event Type
    Other
    Date Received
    January 30, 2006
    Date of Event
    January 4, 2006
    Report Date
    January 30, 2006
    Manufacturer
    MEDISPEC LTD
    Product Code
    LNS
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT LEFT EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY. AFTER THE PROCEDURE,THE ESWL SPARK PLUG HAD AN ODD APPEARANCE. THE RIPS WERE OFF CENTER AND NOT IN ALIGNMENT. THE SURGEON WAS SHOWN SPARK PLUG. HE ALSO FELT THAT THIS WAS NOT NORMAL. CLINICAL ENGINEERING WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISPEC ESWL ELECTRODE-SPARK PLUG LNS MEDISPEC LTD 280605MX1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR