BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3634773 · Received February 19, 2014

    Report

    Report Number
    1723170-2014-00150
    Event Type
    Injury
    Date Received
    February 19, 2014
    Date of Event
    January 20, 2014
    Report Date
    May 17, 2017
    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

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE CAMERA CABLE WAS REPLACED AND THE SURGERY WAS COMPLETED WITHOUT FURTHER ISSUE ON THE FOLLOWING FRIDAY. CORRECTION: ON THE INITIAL MDR IT WAS STATED THE PATIENT WEIGHT WAS NOT PROVIDED BY THE SITE, BUT IT SHOULD HAVE READ, "THE PATIENT AGE WAS NOT AVAILABLE FROM THE SITE." THE CAMERA MAST WAS ALSO REPLACED AND RETURNED. THE CAMERA MAST WAS FOUND TO HAVE PHYSICAL DAMAGE TO THE COLLAR OF THE SLEEVE INSERT, WHICH HAD A PIECE BROKEN OUT OF IT.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT MADE AVAILABLE FROM THE SITE. (B)(4) 2014, MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED EXCEPT HARDWARE. FINDING WAS THAT THE CAMERA WAS NOT RECEIVING POWER; SWITCHING THE INTERNAL POWER CABLE AND CAMERA DID NOT RESOLVE THE ISSUE. - REPLACEMENT SHORT CAMERA MAST SHIPPED TO SITE 02/04/2014. - REPLACEMENT PSU SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED (ON (B)(4) 2014), SUSPECT DEVICE FINDS THAT WHEN CONNECTED TO A KNOWN GOOD SYSTEM THE PSU WAS FOUND TO BE FULLY FUNCTIONAL. THE PSU PASSED AN AAK TEST. DEVICE DID NOT CAUSE EVENT. - REPLACEMENT SCU KIT SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED (ON (B)(4) 2014) SUSPECT DEVICE FINDS THAT WHEN CONNECTED TO A KNOWN GOOD SYSTEM THE SCU PERFORMED AS EXPECTED WITHOUT ISSUE. A CHECK OF THE EVENT LOG REVEALED INTERMITTENT CONNECTION ISSUES WITH THE PSU THAT CAN BE ATTRIBUTED TO THE DAMAGED EXTERNAL SCU TO PSU CABLE THAT WAS ALSO REPLACED. FULLY FUNCTIONAL. DEVICE DID NOT CAUSE EVENT. - REPLACEMENT INT SCU TO PSU CABLE SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED (ON (B)(4) 2014) SUSPECT CABLE FOUND IT TO BE IN GOOD CONDITION WITH NO DAMAGE. WHEN CONNECTED TO KNOWN GOOD SYSTEM THE CABLE WAS FOUND TO BE FULLY FUNCTIONAL. DEVICE DID NOT CAUSE EVENT. - REPLACEMENT SCU TO I/O HUB CABLE SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED (ON (B)(4) 2014) SUSPECT CABLE FOUND IT PASSED A CONTINUITY CHECK WITH NO OPENS OR SHORTS DETECTED. THERE IS NO PHYSICAL DAMAGE TO THE CABLE. NO PROBLEM FOUND. DEVICE FOUND TO BE FULLY FUNCTIONAL AND DID NOT CAUSE EVENT. - REPLACEMENT EXT SCU TO R/A PSU CABLE SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED (ON (B)(4) 2014) SUSPECT CABLE FOUND IT HAD BEEN CRUSHED 73 1/2 INCHES FROM THE RIGHT ANGLE LEMO CONNECTOR. THE INTERNAL CABLES HAD BEEN VARIOUSLY CRUSHED AND SEVERED CAUSING INTERMITTENT CONNECTION ISSUES. PHYSICAL DAMAGE, CABLE-CUT/DAMAGED, DIRECTLY CAUSED EVENT. (B)(4) 2014, MEDTRONIC REPRESENTATIVE REPLACED THE SCU AND ALL CABLES TO THE CAMERA. PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. ISSUE RESOLVED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED RECEIVING RED STATUS FOR THE CAMERA AND NO LEDS ON THE CAMERA WERE LIT. THIS OCCURRED WHILE IN A SPINE PROCEDURE. THE AMBER LIGHT ON THE SYSTEM CONTROL UNIT (SCU) BOX WAS LIT AND FLASHING. THE SCU UTILITY CONFIGURATION DID NOT HAVE A CAMERA ICON AVAILABLE TO SELECT. THE SCU BOX WAS REPORTING NO CONNECTION TO THE POSITIONING SENSOR UNIT. RE-STARTING THE NAVIGATION SYSTEM AND RE-SEATING THE CABLES DID NOT RESOLVE THE ISSUE. FURTHER TROUBLE-SHOOTING WAS PERFORMED, HOWEVER, REPORTED ISSUE PERSISTED. THE SURGERY WAS HALTED AFTER DECOMPRESSION WHEN IT WAS FOUND THAT THE NAVIGATION SYSTEM CAMERA WAS NOT FUNCTIONING. THE SURGEON OPTED TO CLOSE THE PATIENT AND WAIT UNTIL NAVIGATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105826 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention