BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2974168 · Received February 22, 2013

    Report

    Report Number
    1723170-2013-00127
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    February 1, 2011
    Report Date
    January 24, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARCHIVE WAS DELETED AND NOT RETURNED FOR ANALYSIS. MEDTRONIC NAVIGATION WAS UNABLE TO DETERMINE ROOT CAUSE WITHOUT FURTHER INFORMATION SINCE THE ON-GOING INVESTIGATION PROVED TO BE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED. THE SURGEON IN THE REPORTED EVENT HAS SUBSEQUENTLY PERFORMED OVER 15 SUCCESSFUL NEUROLOGICAL BASED SURGERIES USING NAVIGATION WITHOUT ANY ADDITIONAL ALLEGATIONS OF INACCURACY ACCORDING TO THE ACCOUNT HISTORY AND DOCUMENTED SURGERY COVERAGES.

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND WEIGHT WERE NOT AVAILABLE FROM THE ORIGINAL REPORT. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, MEDTRONIC RECEIVED A LEGAL DOCUMENT THAT ALLEGED AN INACCURACY OF UNSPECIFIED AMOUNT WHILE IN A CRANIAL BIOPSY AND SHUNT PROCEDURE ON (B)(6) 2011. THE ALLEGED PROCEDURE WAS A STEALTH-GUIDED ENDOSCOPIC BIOPSY OF A PINEAL CYST AND PLACEMENT OF EXTERNAL VENTRICULOSTOMY DRAIN USING A STEALTHSTATION NAVIGATION SYSTEM. THE DOCUMENT ALLEGED THAT AFTER THE PROCEDURE, THE SURGEON INFORMED THE PATIENT THAT HE BELIEVED THE NAVIGATION SYSTEM MAY HAVE CAUSED HIM TO ERRONEOUSLY ENTER AN AREA OF HER BRAIN THAT HE DID NOT INTEND TO ENTER. THE DOCUMENT ALSO ALLEGED THAT THE PATIENT HAD SUFFERED PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78096 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability