BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIRECTLINK ICP MODULE

    MDR report key: 10952985 · Received December 5, 2020

    Report

    Report Number
    3013886523-2020-00227
    Event Type
    Injury
    Date Received
    December 5, 2020
    Date of Event
    November 16, 2020
    Report Date
    March 30, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    PMA / PMN Number
    K152670
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MICROSENSOR WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - LOT 3951663 SN (B)(6), CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - DIRECTLINK MODULE 82-6828, SN (B)(6) : THE MODULE PASSED THE INSPECTION AND FUNCTIONAL TESTS. THE CABLE 82-6840: THE CABLE PASSED THE INSPECTION AND FUNCTIONAL TESTS. ISSUE IS NOT CONFIRMED AS BOTH DEVICES FUNCTIONED CORRECTLY. THE ROOT CAUSE OF THE ISSUE REPORTED BY CUSTOMER COULD NOT BE DETERMINED AS THE DEVICE WORKED CORRECTLY. HOWEVER, THE POSSIBLE ROOT CAUSE OF THE DEFECT REPORTED BY THE CUSTOMER COULD BE DUE MULTIPLEXER FAILURE (0MMHG OR 100MMHG TRANSFERRED INSTEAD OF ICP PROBE SIGNAL).

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2020-00228. A FACILITY REPORTED THAT ON (B)(6) 2020 THE CODMAN DIRECTLINK WAS SET UP WITH THE CERELINK ICP SENSOR. INITIALLY IN THE THEATRE THE READING WAS OK. LATER THE SAME DAY IN THE ICU THE READING WAS AROUND -14. THE INTEGRA ACCOUNT MANAGER TALKED THROUGH CALIBRATION OVER THE PHONE. THE READING WAS THEN MINUS 1. THE SENSOR WAS KEPT INSITU AND THE PATIENT WENT BACK INTO THE THEATRE ON (B)(6) 2020 FOR ANOTHER PROCEDURE AND THIS WAS TO INCLUDE INSERTION OF ANOTHER CERELINK ICP SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418373 DIRECTLINK ICP MODULE DIRECTLINK - MODULE GWM INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1