BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHOPLASTY

    MDR report key: 2132884 · Received June 17, 2011

    Report

    Report Number
    2953769-2011-00078
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: PRIOR TO STARTING A KYPHOPLASTY PROCEDURE, THE PATIENT (IN HER (B)(6)) WAS MOVED TO A PRONE POSITION ON THE TABLE AND VITAL SIGNS DECLINED RAPIDLY. IT WAS DECIDED TO ABORT THE CASE AND CALL A CODE BLUE. THE PROCEDURE WAS NOT STARTED OR COMPLETED. AS OF (B)(6) 2011, THE PATIENT WAS AWAKE AND ALERT, BUT EXPERIENCING SHORT TERM MEMORY LOSS. IT IS BELIEVED THAT THE INCIDENT WAS ANESTHESIA RELATED. 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 Hospitalization| L