BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONITORR ICP¿ EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM

    MDR report key: 7511416 · Received May 14, 2018

    Report

    Report Number
    7511416
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    April 14, 2016
    Report Date
    May 2, 2018
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BEING PREPARED TO GO FOR A CT SCAN WHEN THE TRANSDUCER TO THE VENTRICULAR WAS FOUND HANGING BY THE BED, NOT CONNECTED. NEUROSURGERY PHYSICIAN CAME TO ROOM TO REPLACE IT. DURING THE INVESTIGATION OF THE EVENT IT WAS DETERMINED THAT WE ARE UNCERTAIN OF THE LOT NUMBERS BECAUSE THE PRODUCT BROKE AFTER THE PACKAGING WAS DISCARDED. MANUFACTURER RESPONSE FOR CSF DRAINAGE SYSTEM, (BRAND NOT PROVIDED) (PER SITE REPORTER). SUPPLY CHAIN STAFF AND PATIENT STAFF HAVE MET WITH THE COMPANY SALES REPRESENTATIVE FROM INTEGRA LIFE SCIENCES TO GET A BETTER UNDERSTANDING OF THE EVENT. THE INVESTIGATION IS CONTINUING. THERE WERE 3 LOT NUMBERS AS OF MID-(B)(6) IN THE STOREROOM BUT UNSURE OF THE LOT NUMBER OF THE FAILED PRODUCT/SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354011 MONITORR ICP¿ EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG INTEGRA LIFESCIENCES CORPORATION INS1100 ?1170825; ?1173032; ?1172838

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT KNOWN.