BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECTLINK ICP MODULE

    MDR report key: 22472357 · Received July 10, 2025

    Report

    Report Number
    3013886523-2025-00168
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Report Date
    September 26, 2025
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    PMA / PMN Number
    K152670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE DIRECTLINK ICP MODULE WAS NOT RETURNED FOR EVALUATION (IS NOT AVAILABLE FOR RETURN AS PER CUSTOMER); THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE 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.

    Additional Manufacturer Narrative · 0

    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 · 0

    5 OF 6 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2025-00164, 3013886523-2025-00165, 3013886523-2025-00166, 3013886523-2025-00167, 3013886523-2025-00169. THIS REPORT IS FOR THE DIRECTLINK ICP MODULE AS THE CUSTOMER INDICATED THE EVENT OCCURRED SEVERAL TIMES. A PHYSICIAN EXPRESSED A LOSS OF CONFIDENCE IN CERELINK ICP SENSORS. THEY ESTIMATE THAT IN 50% OF THE CASES WHERE A PATIENT HAD AN CERELINK ICP SENSOR AND A CHECK OF ICP WITH A FFT (FLUID FILLED TRANSDUCER) VIA THE EXTERNAL DRAINAGE SYSTEM THEY NOTICED A DECLINE AND DIFFERENCE THAT BECOMES BIGGER AND BIGGER (CFR DRIFT) AFTER A COUPLE OF DAYS. THEY DOUBLE CHECK THE FFT MEASUREMENT AS THIS IS POSITIONING (HIGHT) DEPENDANT, HOWEVER DON'T NOTICE MISTAKES WITH EVD SYSTEM, SO THEY CONCLUDED WRONG MEASUREMENT OF CERLINK SENSOR (USE THIS TOGETHER WITH DIRECTLINK). ADDITIONAL INFORMATION RECEIVED: IS IT POSSIBLE TO KNOW HOW MANY TIMES THIS TYPE OF DYSFUNCTION WAS OBSERVED? IF YES, HOW MANY AND APPROXIMATE DATE? ANSWER: THEY ESTIMATE 50% OF THE CASE, AND AS I COUNT 38 PROBES SINCE 2023. I BELIEVE 18 WOULD BE AN EDUCATED ESTIMATION. FOR EACH CASE, DID THEY REMOVE THE SENSOR? HOW DID THEY FOLLOW THE MONITORING? ANSWER: THEY NOTICED THE INCONSISTENCY AS THEY SIMULTANEOUSLY MEASURED ICP WITH A FLUID FILLED TRANSDUCER ON THEIR SYSTEM FOR EXTERNAL DRAINAGE. SO, THEY KEPT THE SENSOR IN AS LONG AS POSSIBLE TO KEEP MEASURING ICP IN 2 WAYS, RELYING MORE ON FFT THAN CERELINK. FOR EACH PATIENT, WERE THERE ANY CONSEQUENCES? IF YES, PLEASE DESCRIBE. ANSWER: FOR SOME PATIENT THEY SAW THAT THE ICP WAVE WAS ¿FLATTENED¿, AND AS A CONSEQUENCE NOT RELIABLE ANYMORE SO THEY SWITCHED TO EVD (PROBABLY EARLIER) SO SOME OF THOSE PROCEDURES COULD HAVE BEEN AVOIDED IF SENSOR WAS WORKING AS EXPECTED. (THEN A PLACEMENT OF EXTERNAL DRAINAGE COULD HAVE BEEN AVOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279752 DIRECTLINK ICP MODULE DIRECTLINK - MODULE GWM INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown