BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDI PASSIVE SPHERES

    MDR report key: 5057119 · Received September 4, 2015

    Report

    Report Number
    3002743211-2015-00049
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    July 30, 2015
    Report Date
    August 7, 2015
    Manufacturer
    NORTHERN DIGITAL INC.
    Product Code
    HAW
    PMA / PMN Number
    K033621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS COMMUNICATED BY A MEDTRONIC REPRESENTATIVE WHO REPORTED THAT A SITE (B)(6) HAD SPHERES THAT DID NOT TRACK. SITE REPLACED SPHERES AND CONTINUED WITH PROCEDURE WITH NO ADVERSE EVENT. LOT NUMBER IS UNKNOWN. SITE REPORTED THAT THERE WAS NO FLUID ON THE SPHERES. HOWEVER WHEN SPHERES WERE RETURNED TO MEDTRONIC, THE SPHERE WERE EVALUATED AND REPORTED AS "OBVIOUSLY BEEN USED". MEDTRONIC CLEANED AND STERILIZED SPHERE AND NOTED SPHERES COULD TRACK EXCEPT WHEN ROTATED. COMPLAINANT REPORTED THAT THERE WAS NO PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587472 NDI PASSIVE SPHERES REFLECTIVE PASSIVE MARKER SPHERES HAW NORTHERN DIGITAL INC. 8801075

    Patients

    Seq Age Sex Outcome Treatment
    1