BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR PROBE TIP

    MDR report key: 3021685 · Received March 26, 2013

    Report

    Report Number
    1723170-2013-00235
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    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 LUMBAR PROBE SHIPPED TO SITE (B)(4) 2013. SUSPECT DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR INSPECTION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINE PROCEDURE, THE TIP OF A NAVLOCK LUMBAR PROBE WAS BENT IN THE PATIENT. THE LUMBAR PROBE DID NOT BREAK, NO PARTICLES WERE LEFT BEHIND. THE SURGEON USED A THORACIC PROBE FOR THE REMAINDER OF THE SURGERY AND COMPLETED THE PROCEDURE WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124464 LUMBAR PROBE TIP NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 100213

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR