BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEALTHSTATION TREON PLUS

    MDR report key: 926103 · Received October 12, 2007

    Report

    Report Number
    1723170-2007-00006
    Event Type
    Other
    Date Received
    October 12, 2007
    Date of Event
    May 16, 2007
    Report Date
    September 25, 2007
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THIS CASE, AND THE PT OUTCOME - NO INFORMATION HAS BEEN MADE AVAILABLE TO DATE. RELATED SYSTEM IS FUNCTIONAL AS PER MNAV STAFF WHO HAVE CONDUCTED TRAINING AND PROVIDED SURGICAL COVERAGE SINCE INCIDENT. UNABLE TO IDENTIFY/CONFIRM ANY SYSTEM FAILURE.

    Description of Event or Problem · 1

    MNAV CASS WAS INFORMED 05/24/07 BY OR STAFF OF A CRANIOTOMY CASE FROM THE PRIOR WEEK. CASS WAS INFORMED THAT THE PT WAS REGISTERED, AND THEN DR USED THE PROBE AND CONFIRMED THE REGISTRATION WAS ACCURATE. HE THEN LEFT THE OR TO SCRUB IN, WHEN HE RETURNED AND STARTED THE CASE HE USED, THE STEALTH PROBE ON THE PT TO PLAN HIS INCISION AND COMMENTED THE NAVIGATION WAS OFF. THE NURSE WORKING IN THE ROOM ASKED HIM IF HE WOULD LIKE TO RE-REGISTER THE PT, TO WHICH HE ALLEGEDLY REPLIED NO. CASS WAS TOLD BY THE OR STAFF THAT THEY HAD SUSPECTED THE ANESTHESIOLOGIST HAD LEANED ON THE STEALTH FRAME AND CAUSED IT TO MOVE WHILE CONNECTING SOME PT LINES WHILE DR WAS SCRUBBING IN. DR CONTINUED TO USE NAVIGATION DURING HIS SURGERY. OR STAFF INFORMED CASS THAT THE PT HAD SUFFERED SOME PARALYSIS FROM THE SURGERY, ALTHOUGH THE EXTENT HAS NOT BEEN PROVIDED TO MNAV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON PLUS STEREOTACTIC SURGICAL SYSTEM HAW MEDTRONIC NAVIGATION, INC. 9680111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other