BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEALTHSTATION S7 TREATMENT GUIDANCE SYSTEM

    MDR report key: 1744640 · Received June 29, 2010

    Report

    Report Number
    1723170-2010-00033
    Event Type
    Other
    Date Received
    June 29, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 1, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT BUT HAS BEEN REQUESTED. DEVICE WAS INVESTIGATED ON-SITE AND INACCURACY WAS NOT REPEATABLE ON A TEST MODEL. SYSTEM WAS ACCURATE.

    Description of Event or Problem · 1

    DOCTOR REPORTS THAT THE LAST 2 BIOPSIES HE TOOK RESULTED IN NON-DIAGNOSTIC TISSUE BEING TAKEN. THE STEALTH STATION S7 WAS USED. THERE WAS NO IMPACT TO THE PATIENT. THE MEDTRONIC SALES REPRESENTATIVE TESTED SYSTEM AND COULD NOT REPLICATE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 TREATMENT GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION S7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK