BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9733856 S7 STAFF ASSEMBLED 110V

    MDR report key: 8668471 · Received June 4, 2019

    Report

    Report Number
    1723170-2019-02932
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    November 10, 2017
    Report Date
    June 4, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: SYNERGY SPINE S7;I7 2.1 9733686; VERSION 2.1.0 K131425, (B)(4). THIS DEVICE IS NOT APPROVED/MARKETED IN THE US, BUT IS SIMILAR TO A DEVICE THAT IS APPROVED IN THE US UNDER K050438. THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. THE ISSUE WAS NOTED INT INTRA-OPERATIVELY AND HAD NO IMPACT ON THE PATIENT OUTCOME. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO CREATE MULTIPLE DIFFERENT REGISTRATION PLANS BUT ALL OF THEM WERE THE SAME PLAN. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE NAVIGATION. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461215 CART 9733856 S7 STAFF ASSEMBLED 110V INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9734056

    Patients

    Seq Age Sex Outcome Treatment
    1