BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION

    MDR report key: 8504172 · Received April 11, 2019

    Report

    Report Number
    1723170-2019-01686
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 15, 2019
    Report Date
    May 14, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE. A SYSTEM CHECKOUT IS IN PROGRESS BUT HAS NOT YET BEEN COMPLETED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. HOWEVER, AFTER REPLACING THE SUSPECTED COMPONENTS, THE ISSUE DID NOT RESOLVE. A SYSTEM CHECKOUT WAS CANCELLED BECAUSE THE ACCOUNT TEAM UPDATED THE SITE TO THE LATEST MODEL. ANALYSIS OF THE SPLITTER, MODEL# 9732266, LOT# V73015LK00242, FOUND NO FAULT. WHEN CONNECTED TO A KNOWN GOOD SYSTEM THE RETURNED SPLITTER DISPLAYED A GOOD IMAGE FOR EACH OUTPUT. ANALYSIS OF THE LCD CABLE, MODEL# 9733577, LOT# 180426, FOUND PHYSICAL DAMAGE. THE CONNECTION WAS BENT FLAT, WHICH MADE CONTACT WITH THE CONNECTOR SHELL. ANALYSIS OF THE COMPUTER, MODEL# 9734477, LOT# 1721574, FOUND NO FAULT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED CATHETER PLACEMENT. IT WAS REPORTED THAT INTRA-OPERATIVELY, BOTH SYSTEM MONITORS WENT BLACK. THE SITE REBOOTED THE SYSTEM WITH NO CHANGE. THE SITE STATED THAT THE MONITORS WERE BLACK AND DID NOT SHOW "NO INPUT DETECTED". NAVIGATION WAS ABORTED. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING AFTER REPLACEMENT OF SUSPECT PARTS, THE ISSUE WAS NOT RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE INDICATED THAT AFTER REPLACING ALL THE SHIPPED COMPONENTS, THE ISSUE WAS NOT RESOLVED. THE MANUFACTURER REPRESENTATIVE CONFIRMED THERE WAS NO POWER TO THE VIDEO SPLITTER. THE POWER WAS RESEATED TO THE MULTI-OUT POWER SUPPLY AND NO GREEN LIGHT ON THE MULTI-OUT POWER SUPPLY WAS OBSERVED. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE INDICATED THAT NO REPAIRS WERE PERFORMED ON THE NAVIGATION SYSTEM BECAUSE THE ACCOUNT TEAM UPDATED THE SITE TO THE LATEST MODEL. THE ENTIRE SYSTEM AND PARTS WERE SENT BACK. THE SYSTEM CHECK OUT WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298589 STEALTHSTATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR