BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7

    MDR report key: 12268745 · Received August 3, 2021

    Report

    Report Number
    1723170-2021-01980
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 16, 2021
    Report Date
    August 3, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PARTS WERE RETURNED FOR ANALYSIS. CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 960-537, SERIAL/LOT #: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL BIOPSY. IT WAS REPORTED THAT DURING A CASE AND AFTER REGISTRATION THE VERTEK ARM MOVED. THE SITE SAID THEY WERE UNABLE TO FULLY LOCK THE ARM. THE SITE ABORTED THE CASE AS THEY HAVE HAD PREVIOUSLY HAD ISSUES WITH REGISTERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166067 STEALTHSTATION S7 NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR