BEUDAMED
    FDA Adverse Event Injury Summary report: N

    150 MM CANNULA

    MDR report key: 3250673 · Received July 26, 2013

    Report

    Report Number
    1723170-2013-00552
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER NOT AVAILABLE AS SUSPECT DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURE DATE DEPENDENT ON LOT NUMBER, THEREFORE, NOT AVAILABLE. SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED TO MANUFACTURER FOR INVESTIGATION. THE MEDTRONIC REPRESENTATIVE REPORTING THE FIRST SURGERY STATED THE SURGEON AND CHIEF RESIDENT EASILY PLACED THE PIN TO BEGIN WITH AND NAVIGATION PROCEEDED NORMALLY. THE SCREW PLACEMENT WAS COMPLETE AND NO MENTION WAS MADE OF ANY PROBLEMS. FOLLOW-UP BY ANOTHER MEDTRONIC REPRESENTATIVE REGARDING THE SECOND SURGERY ((B)(6) 2013) ON THIS PATIENT, FINDS THIS PROCEDURE WAS TO PLACE A LUMBAR DRAIN, AND REPAIR PSEUDOMENINGOCELE. THIS SURGERY WAS NOT RELATED TO THE FIRST CASE BUT THE DOCTOR FOUND THE SLEEVE DURING IMAGING DONE FOR THE SECOND SURGERY. THIS DOCTOR REMOVED THE SLEEVE DURING THE SECOND SURGERY. THERE IS NO INDICATION THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT OF A SURGERY THAT TOOK PLACE APPROXIMATELY ONE MONTH PRIOR TO THIS REPORT. IT WAS STATED THAT A PERC PIN CANNULA HAD BEEN LEFT INSIDE A PATIENT DURING A SPINAL FUSION SURGERY. DUE TO ISSUES RELATED TO THE SPINAL FUSION THERAPY, THE PATIENT WAS TAKEN INTO A SECOND SURGERY, (DATE UNKNOWN). IT WAS UNCLEAR HOW IT WAS DISCOVERED THAT THE PERC PIN CANNULA HAD BEEN LEFT INSIDE THE PATIENT, HOWEVER, IT WAS KNOWN THAT THE CANNULA WAS REMOVED DURING THE SECOND PROCEDURE. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S 150 MM CANNULA. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350556 150 MM CANNULA NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention