BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC PROBE TIP

    MDR report key: 3140498 · Received May 31, 2013

    Report

    Report Number
    1723170-2013-00392
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SITE DECLINED TO PROVIDE ANY PATIENT DEMOGRAPHIC INFORMATION. (B)(4) ISSUED. REPLACEMENT PROBE SHIPPED TO SITE (B)(6) 2013. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THE TIP OF THE PROBE IS SEVERELY TWISTED. PHYSICAL DAMAGE, DEFORMATION, DIRECTLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    A HOSPITAL REPRESENTATIVE REPORTED THAT A THORACIC PROBE BECAME BENT DURING A SPINE SURGERY. IT WAS STATED THAT THE PROBE BENT DURING USE AS THE PATIENT'S BONE WAS VERY HARD. 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
    241093 THORACIC PROBE TIP NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120926

    Patients

    Seq Age Sex Outcome Treatment
    1