BEUDAMED
    FDA Adverse Event Death Summary report: N

    KYPHOPLASTY

    MDR report key: 2200335 · Received August 11, 2011

    Report

    Report Number
    2953769-2011-00097
    Event Type
    Death
    Date Received
    August 11, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD; FOLLOWED UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A KYPHOPLASTY PROCEDURE, PLANNED FOR LEVELS T11, T12 AND L1 IN THE PRONE POSITION. 10CC OF XPEDE PMMA WAS INJECTED AT EACH LEVEL. AS THE PHYSICIAN WAS REMOVING THE TROCARS AFTER THE LAST FILL AT L1, HYPOTENSION WAS OBSERVED BY THE ANESTHESIOLOGIST. THE PATIENT WAS SUTURED AND TURNED OVER ON THE TABLE. WITHIN 10 MINUTES OF THE HYPOTENSION, THE PATIENT WENT INTO FULL CARDIAC ARREST. RESUSCITATION MEASURES WERE IMPLEMENTED BY MEANS OF CPR AND ADMINISTRATION OF TWO INJECTIONS OF EPINEPHRINE; HOWEVER, THE PATIENT EXPIRED. ACTIVE C-ARM WAS USED DURING THE CASE. FILMS WERE TAKEN UP TO THE TIME OF THE CARDIAC ARREST AND NO IRREGULARITIES WERE REPORTED. THERE WAS NO EVIDENCE OF ANY CEMENT EXTRAVASATION. NO AUTOPSY WILL BE PERFORMED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHOPLASTY ARTHROSCOPE HRX MEDTRONIC SPINE LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Life Threatening| O| R