BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC SOFAMOR DANEK

    MDR report key: 4295028 · Received November 24, 2014

    Report

    Report Number
    MW5039318
    Event Type
    Other
    Date Received
    November 24, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 24, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE KYPHON BALLOON WAS INFLATED TO 250 PSI FOR THE PROCEDURE. AS THE CEMENT WAS BEING INJECTED ON THE OPPOSITE SIDE, THE PHYSICIAN DECREASED THE BALLOON PRESSURE TO 150 PSI. SHORTLY AFTER THIS OCCURRED, THE BALLOON BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762126 MEDTRONIC SOFAMOR DANEK KYPHOPLASTY BALLOON CATHETER HRX MEDTRONIC SOFAMOR DANEK KYPHOPAK EXPRESS II TRAY 1ST FX 0007286829

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR