BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSIVE PLANAR BLUNT PROBE

    MDR report key: 4133536 · Received October 1, 2014

    Report

    Report Number
    1723170-2014-01039
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 3, 2014
    Report Date
    November 9, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K972398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA ISSUED. REPLACEMENT PASSIVE PLANAR PROBE SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT PASSIVE PLANAR PROBE FINDS THAT THE PROBE WAS IN GOOD CONDITION. WITH MARKERS ATTACHED AND FULLY SEATED, THE PROBE RETURNED GOOD GEOMETRY AND DIVOT ERROR READINGS. NO PROBLEM FOUND. DEVICE FOUND TO BE FULLY FUNCTIONAL. DID NOT CAUSE EVENT. A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, COULD NOT REPLICATE THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    CORRECTION: ON 13-OCT-2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT FROM A SITE THAT WHILE IN A CRANIAL PROCEDURE, THE SURGEON ALLEGED A 3MM INACCURACY WITH THEIR PASSIVE PLANAR PROBE. WHEN TOUCHING THE SAME KNOWN BONY ANATOMY WITH THE SCOPE PROBE AND PASSIVE PLANAR PROBE, THE PLANAR APPEARED TO BE 3MM INACCURATE. NO FURTHER DETAILS WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612359 PASSIVE PLANAR BLUNT PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 200505030032

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR