BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP RX

    MDR report key: 293737 · Received August 8, 2000

    Report

    Report Number
    2124215-2000-02061
    Event Type
    Injury
    Date Received
    August 8, 2000
    Date of Event
    June 14, 2000
    Report Date
    June 14, 2000
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS VENTRICULAR PACING LEAD WAS AN ATTEMPTED IMPLANT WHICH WAS NOT USED BECAUSE OF ADVANCEMENT AND PLACEMENT DIFFICULTIES. IT TOOK 30 MINUTES TO PASS THE LEAD THROUGH THE TRICUSPID VALVE BECAUSE IT WENT INTO THE INFERIOR VENA CAVA. AFTER PASSING IT THROUGH THE ATRIUM, THE HELIX BECAME CAUGHT IN TISSUE NEAR THE VALVE AND COULD NOT BE REMOVED USING COUNTER CLOCKWISE MOTION. FORCE WAS NECESSARY TO REMOVE IT, CAUSING THE HELIX TIP TO BREAK OFF IN THE TISSUE. THE PHYSICIAN COMMENTED THAT THE MODEL IS DIFFICULT TO IMPLANT BECAUSE THE BODY IS TOO SOFT, AND HE SUSPECTS THE INTEGRITY OF THE STRUCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP RX BIPOLAR LEAD LWS CARDIAC PACEMAKERS 4244 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention