BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER

    MDR report key: 7628606 · Received June 22, 2018

    Report

    Report Number
    9612007-2018-00014
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    May 29, 2018
    Report Date
    June 5, 2018
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    GWM
    PMA / PMN Number
    040235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 21JUN2018 INDICATING THAT AFTER PROBE INSERTION, THE ABNORMAL FLUCTUATIONS WERE NOTED UP UNTIL IT WAS REMOVED APPROXIMATELY 6-7 DAYS. IT WAS ALWAYS ABNORMALLY FLUCTUATING BUT DID SLOW DOWN AFTER 24 HOURS AND GOT LITTLE BETTER EVERYDAY. FEW COMPUTED TOMOGRAPHY OF HEAD WAS DONE AFTER TO VERIFY THE PROBE LOCATION. THE NEUROSURGEON CONFIRMED THAT IT IS IN THE WHITE MATTER HOWEVER, THERE WAS AN AXIAL HEMATOMA JUST ABOVE IT. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE EVENT REPORTED OXYGEN PRESSURE VALUES IN THE LICOX SYSTEM FLUCTUATED QUICKLY BETWEEN 21 AND 23 MMHG, WHEN USED WITH A LICOX PROBE REF IP2P. NO TRACEABILITY INFORMATION WAS INITIALLY AVAILABLE; THE PROBE WAS DISCARDED. FROM THE HOSPITAL, REF IP2P PROBE COULD BE EITHER FROM LOT # 0203216 (SN (B)(4)) OR FROM LOT # 0202186 (SN (B)(4)). EACH PROBE IS TESTED WITHIN SPECIFICATIONS AT TIME OF MANUFACTURING AND PROBES FROM BOTH LOTS WERE TESTED WITHIN SPECIFICATIONS AT TIME OF MANUFACTURING, AS SHOWN ON THE DEVICE HISTORY RECORDS. THE PROBE IS NOT AVAILABLE FOR INVESTIGATION, THEREFORE COMPLAINT REPORTED CANNOT BE VERIFIED, AND WITH THE ADDITIONAL INFORMATION CONFIRMING CORRECT PROBE PLACEMENT AND SUFFICIENT TIME TO ALLOW PROBE STABILIZATION, THE EXACT CAUSE OF THE REPORTED RAPID FLUCTUATIONS COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT WILL NOT BE RETURNED FOR EVALUATION SINCE IT HAD BEEN DISCARDED BY THE CUSTOMER. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A REGULATORY AFFAIRS ASSOCIATE REPORTED ON BEHALF OF THE CUSTOMER THAT AN IP2P PROBE KIT WAS USED ON (B)(6) 2018 AND THE VALUES IN THE LCX02 MONITOR FLUCTUATED QUICKLY BETWEEN 21 AND 23. ADDITIONAL FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2018 STATING THAT THE IP2P CATHETER WAS INSERTED ON A (B)(6) YEAR OLD MALE PATIENT AND WHEN LOOKING AT THE LICOX VALUE ON THE MONITOR, ONE OF THE STAFF MEMBERS NOTICED THAT THE NUMBERS WERE TOGGLING ODDLY BETWEEN 2 TO 3 VALUES. AFTER THE PRODUCT ISSUE OCCURRED, THE EQUIPMENT WAS USED AS IF THERE WAS NO ISSUE. THE CUSTOMER DID NOT BELIEVE THAT THERE WAS ANY PATIENT INJURY. SINCE THE CATHETER HAD BEEN DISCARDED, THE CUSTOMER WAS NOT CERTAIN OF THE CATHETER LOT OR SERIAL NUMBER; COULD POSSIBLY BE LOT NUMBER 0203216 WITH SERIAL NUMBER (B)(4) OR LOT NUMBER 0202186 WITH SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472160 KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER LICOX BOLTS CATHETERS & KITS GWM INTEGRA NEUROSCICENCS IMPLANTS SA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR LCX02 MONITOR| LCX02 MONITOR