BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECTLINK ICP MODULE

    MDR report key: 9167794 · Received October 8, 2019

    Report

    Report Number
    1226348-2019-00455
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 16, 2019
    Report Date
    September 17, 2019
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    PMA / PMN Number
    K152670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UDI (B)(4). THE DIRECTLINK MODULE 82-6828 WITH SN (B)(4), LOT NUMBER 193667 WAS TESTED ACCORDING TO PROCEDURE, AND NO ISSUE WERE IDENTIFIED. THE DEVICE FUNCTIONS CORRECTLY. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND THE DEVICE WAS FOUND TO HAVE CONFORMED TO SPECIFICATION WHEN RELEASED. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED ISSUE WAS NOT CONFIRMED AND NO ROOT CAUSE COULD BE DETERMINED AS THE DIRECTLINK MODULE WORKED NORMALLY.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS #1 OF THREE REPORTABLE COMPLAINTS, SEE MEDWATCH-1226348-2019-00456 AND MEDWATCH-1226348-2019-00457.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DIRECT LINK MONITOR STOPPED READING DURING USE. THE MICROSENSOR THAT WAS IMPLANTED WAS REMOVED BECAUSE THE MONITOR STOPPED READING. THERE WERE TWO IMPLANTS THAT USED THE SAME DIRECT LINK BOX AND CABLES WHICH WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961046 DIRECTLINK ICP MODULE DIRECTLINK - MODULE GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 193667

    Patients

    Seq Age Sex Outcome Treatment
    1