BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1971530 · Received January 21, 2011

    Report

    Report Number
    1723170-2011-00057
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    November 11, 2008
    Report Date
    December 23, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND WEIGHT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. MEDTRONIC NAVIGATION, INC. IS FILING THIS MDR TO ENSURE VISIBILITY OF A PATIENT EVENT WHICH OCCURRED AFTER A PROCEDURE THAT UTILIZED A MEDTRONIC NAVIGATION SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT A MEDTRONIC SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE NOTICE OF LITIGATION FURTHER STATES THAT FOLLOWING SURGERY, THE PLAINTIFF/PATIENT "DEVELOPED BRAIN SHIFT, SEIZURES, COGNITIVE DEFICITS AND AMNESIA." AS A RESULT, THE PATIENT "SUFFERED AND CONTINUES TO SUFFER INTENSE PAIN...DISABILITY AND DISFIGUREMENT." INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. SUBSEQUENT SYSTEM CHECKOUTS AT THE SITE SHOWED THAT THE SYSTEM WAS FULLY FUNCTIONAL. THERE WERE SEVERAL SUCCESSFUL SURGERIES COMPLETED USING THIS SYSTEM AFTER THE REPORTED EVENT.

    Description of Event or Problem · 1

    MEDTRONIC NAVIGATION, INC. WAS MADE AWARE OF THIS EVENT ON (B)(6) 2010 VIA A LITIGATION COMPLAINT. THE LITIGATION COMPLAINT RELATES TO A "STEALTH MRI-GUIDED CRANIOTOMY TO REMOVE AN INTRAVENTRICULAR TUMOR" WHERE A MEDTRONIC REPRESENTATIVE PROVIDED SURGICAL SUPPORT. AS THERE WAS NO PRODUCT MALFUNCTION, AND THE PATIENT'S OUTCOME WAS UNKNOWN AT THAT TIME, THIS EVENT WAS NOT PREVIOUSLY REPORTED. WITHIN THE NOTICE OF LITIGATION, IT WAS ALLEGED THAT THE SURGEON COMMITTED ONE OR MORE OF THE FOLLOWING: REMOVED A COAGULATED MURAL NODULE IN A PATIENT FOR WHOM THE PROCEDURE WAS CONTRAINDICATED; REMOVED A COAGULATED MURAL NODULE WITHOUT BEING FIRST ADEQUATELY TRAINED IN THE PROCEDURE; IMPROPERLY PLACED RETRACTORS THROUGH THE FORAMEN OF (B)(4); FAILED TO USE AN INTRAOPERATIVE MRI; AND FAILED TO OPERATE AS A REASONABLY CAREFUL NEUROSURGEON PRACTICING IN THE SAME OR SIMILAR LOCALITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability