BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 7300006 · Received February 27, 2018

    Report

    Report Number
    1723170-2018-00535
    Event Type
    Injury
    Date Received
    February 27, 2018
    Date of Event
    January 5, 2018
    Report Date
    February 27, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND SEX WERE NOT PROVIDED BY JOURNAL ARTICLE AUTHOR. BASED ON THE ARTICLE INFORMATION, THERE WERE 26 MALES AND 21 MALES AVERAGE AGE OF 41.8 YEARS OLD. THEREFORE, MALE AND 42 YEARS OLD WERE USED. PATIENT WEIGHTS WERE NOT AVAILABLE BY THE JOURNAL ARTICLE AUTHORS. EVENT DATE IS APPROXIMATED. DATE PROVIDED IS WHEN THE JOURNAL ARTICLE WAS PUBLISHED. CITATION: JONATHAN C. LAU, SUZANNE E. KOSTENIUK, DAVID R. MACDONALD, AND JOSEPH F. MEGYESI. IMAGE-GUIDED OMMAYA RESERVOIR INSERTION FOR INTRAVENTRICULAR CHEMOTHERAPY: A RETROSPECTIVE SERIES. (2018). ACTA NEUROCHIRURGICA. HTTPS://DOI.ORG/10.1007/S00701-017-3454-Z THE EXACT SYSTEM INFORMATION COULD NOT BE DETERMINED AS IT WAS NOT PROVIDED. HOWEVER, THE SYSTEM LISTED ON THIS FORM WAS AT THE ADDRESS LISTED IN THE ARTICLE DURING THE TIME SOME OF THE SURGERIES WERE COMPLETED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INFORMATION PROVIDED IN THE JOURNAL ARTICLE OR FROM THE AUTHORS. THE AUTHOR COULD NOT PROVIDE ANY ADDITIONAL INFORMATION OR INSIGHT AS HE WAS NOT AT THE SITE WHEN THE SURGERIES WERE PERFORMED. NO REQUEST FOR SERVICE HAVE BEEN RECEIVED FROM THE CUSTOMER REGARDING THESE EVENTS. NO PARTS HAVE BEEN REPLACED OR RETURNED TO THE MANUFACTURER FOR EVALUATION. PER THE JOURNAL ARTICLE, THE INFECTION OCCURRED BEYOND THE EARLY POST-OPERATIVE PERIOD (MORE THAN 1 MONTHS POST-OP) AND AFTER INTRAVENTRICULAR TREATMENT HAD BEEN INITIATED. THE SYSTEM WAS REMOVED 3 MONTHS POST-OP DUE TO ISOLATED INFECTION ON CULTURE. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S IMAGE GUIDANCE SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AUTHOR INDICATED THERE WERE NO CATHETER MALFUNCTION, EARLY INFECTION OR DEATH.

    Description of Event or Problem · 1

    THE ATTACHED JOURNAL ARTICLE WAS FORWARDED BY A MEDTRONIC REPRESENTATIVE. USE OF THE NAVIGATION SYSTEM WAS REPORTED. THIS IS MEDICAL DEVICE REPORT (MDR) THREE OF THREE. SEE 1723170-2018-00533 FOR THE FIRST MDR AND 1723170-2018-00534 FOR THE SECOND MDR. THIS IS A RETROSPECTIVE STUDY FOR THE CASES OCCURRED FROM 2000 TO 2014. FIFTY-FIVE CONSECUTIVE PATIENTS UNDERWENT ORI BY THE SENIOR AUTHOR OVER THE STUDY PERIOD (43.5 ± 16.6 YEARS; 40.0% FEMALE). FORTY-SEVEN OF THOSE PATIENTS UNDERWENT SURGERY WITH NAVIGATION SYSTEM. AVERAGE AGE FOR THE PATIENTS WAS 41.8 YEARS OLD, 26 MALE AND 21 FEMALE PER TABLE 1. ONE (1) CASE OF MALPOSITION, 2 CASES OF INFECTION AND 2 CASES OF HEMORRHAGE WERE REPORTED AS COMPLICATIONS ON TABLE 2 FOR THE PATIENT WHO UNDERWENT SURGERY WITH NAVIGATION. AUTHOR IDENTIFIED TWO INFECTIONS REQUIRING REMOVAL OF THE OMMAYA RESERVOIR IDENTIFIED SEVERAL MONTHS AFTER THE INITIAL SURGERY, BOTH OF WHICH WERE IN THE NAVIGATION GROUP. IN CONCLUSION, USE OF IMAGE GUIDANCE RESULTED IN FEWER OPERATIVE COMPLICATIONS INCLUDING FEWER CATHETER MALPOSITIONS AND MORE SINGLE-PASS PROCEDURES. THE RESULTS SUPPORT ROUTINE USE OF INTRAOPERATIVE IMAGE GUIDANCE FOR PROXIMAL CATHETER INSERTION IN ELECTIVE OMMAYA RESERVOIR PLACEMENT FOR INTRAVENTRICULAR CHEMOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143488 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening| R