BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECTLINK ICP MODULE

    MDR report key: 10949437 · Received December 4, 2020

    Report

    Report Number
    3013886523-2020-00230
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Report Date
    July 15, 2021
    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

    DEVICE HISTORY RECORD (DHR) - LOT 3951662, SN (B)(6), CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE MODULE PASSED THE INSPECTION AND FUNCTIONAL TESTS. THE ROOT CAUSE FOR THE ISSUE "JUMPING FROM POSITIVE TO NEGATIVE" REPORTED BY CUSTOMER COULD NOT BE DETERMINED AS THE DEVICES WORKED CORRECTLY AT THE TIME OF INVESTIGATION. HOWEVER, THE POSSIBLE ROOT CAUSE FOR "PM DISPLAYS WRONG ICP VALUES" COULD BE DUE TO "MULTIPLEXER FAILURE (0MMHG OR 100MMHG TRANSFERRED INSTEAD OF ICP PROBE SIGNAL)".

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFICATION (UDI) : (B)(4). THE DIRECTLINK WAS NOT RETURNED FOR EVALUATION THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    N/A.

    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

    2 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2020-00229. 3013886523-2020-00231. A FACILITY REPORTED INACCURATE INTRACRANIAL PRESSURE READINGS. IT WAS REPORTED INTRACRANIAL PRESSURE READINGS WERE ¿JUMPING¿ FROM POSITIVE TO NEGATIVE WHEN A MICROSENSOR WAS IMPLANTED IN A PATIENT IN THE SURGICAL THEATRE. THE PATIENT WAS IN SURGERY FOR A SUBDURAL HEMATOMA EVACUATION. THE MICROSENSOR WAS INSERTED AND INITIALLY HAD POSITIVE READINGS (AROUND 6-8 MMHG) AND WHEN THE BONE FLAP WAS PUT BACK ON THE READINGS WENT TO NEGATIVE 10 MMHG. AFTER THE PROBLEM OCCURRED, A SECOND DIRECTLINK MODULE WAS SET UP AND THERE WERE SIMILAR ISSUES. A SECOND CERELINK ICP SENSOR AND DIRECTLINK WERE TRIED WITH SIMILAR RESULTS. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 20 MINUTES WHILE TROUBLESHOOTING SET UP. THE INTEGRA ACCOUNT MANAGER WAS PRESENT DURING THE CASE AND ASSISTED WITH SETUP AND TROUBLESHOOTING. THE SAME PATIENT HAD A CERELINK MICROSENSOR AND DIRECTLINK MONITOR SET UP ON (B)(6) 2020 FOR INTRACRANIAL PRESSURE MONITORING AND THIS SURGICAL CASE ON (B)(6) 2020 WAS TO REVISE THAT FIRST SENSOR WHICH ALSO HAD PROBLEMS WITH NEGATIVE READINGS WHEN THE PATIENT WAS IN THE INTENSIVE CARE UNIT (MFG REPORT NUMBERS 3013886523-2020-00227 AND 3013886523-2020-00228).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411471 DIRECTLINK ICP MODULE DIRECTLINK - MODULE GWM INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1