BEUDAMED
    FDA Adverse Event Death Summary report: N

    CERELINK ICP PROBE 1L M BOLT

    MDR report key: 20152620 · Received September 5, 2024

    Report

    Report Number
    3013886523-2024-00272
    Event Type
    Death
    Date Received
    September 5, 2024
    Date of Event
    August 19, 2024
    Report Date
    June 26, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GWM
    UDI-DI
    10381780520889
    PMA / PMN Number
    K173192
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CERELINK SENSOR WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE) 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.

    Additional Manufacturer Narrative · 0

    ROOT CAUSE UPDATE: WITHOUT THE DEVICE RETURN AND THE ABILITY TO ANALYZE THE WAVEFORM, TREND AND DEBUG DATA, THE ABILITY TO REVIEW HOSPITAL RECORDS, OPERATIVE, FOLLOW UP NOTES, ETC., THE ROOT CAUSE CANNOT BE DETERMINED. WE NONETHELESS HEREAFTER ATTEMPT TO MAKE AN ASSESSMENT OF POTENTIAL CAUSES BASED ON THE INFORMATION WE HAVE. THE ALLEGATION OF DEVICE MALFUNCTION CAUSAL TO PATIENT DEMISE FROM AN INACCURATE STATIC READING APPROXIMATELY 15 TO 16 DAYS STATUS POST-IMPLANTATION IS UNSUBSTANTIATED AND HIGHLY UNLIKELY AS THE SENSOR APPARENTLY FUNCTIONED RELIABLY THROUGH DAY 14. NO ELEMENT SUPPORTS A CONCLUSION THAT THE MEDICAL DEVICE FAILED. ON THE CONTRARY, THE INFORMATION AVAILABLE INDICATES THAT THE DEVICE FUNCTIONED APPROPRIATELY: (1) CERELINK WAS NOT REVIEWED, SO NO CONCLUSION CAN BE DRAWN REGARDING A MALFUNCTION. (2) THE DEVICE FUNCTIONED RELIABLY THROUGH DAY 14, CONSISTENT WITH EXPECTED PERFORMANCE AND KNOWN LIMITATIONS OF STRAIN GAUGE SENSORS IN VIVO; AND (3) THE MOST LIKELY EXPLANATION FOR THE ABSENCE OF ELEVATED ICP READINGS IS A BIOLOGICAL RESPONSE SUCH AS ENCAPSULATION. THIS IS PRECISELY WHY PROTOCOLS ADVOCATE FOR MULTIMODAL NEUROMONITORING, TO ENSURE THAT FOREIGN BODY REACTIONS DO NOT COMPROMISE DATA INTERPRETATION AND TO SUPPORT CLINICAL DECISION-MAKING BEYOND THE RECOMMENDED MONITORING PERIOD.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3014334038-2024-00186. A FACILITY REPORTED: "SENSOR IMPLANTED ON 3 AUGUST. DURING THE NIGHT 18-19 AUGUST, INTRA-VENTRICULAR PRESSURE OF PATIENT INCREASE SUDDENLY BUT THE VALUE OF ICP READ ON CERELINK MONITOR AND ON PATIENT MONITOR DID NOT MOVE, IT WAS STABLE. SENSOR EXPLANTED ON 19 AUGUST." - CLINICAL CONSEQUENCE: "BRAIN INVOLVEMENT" - "THEY MONITOR ALTERNATIVELY THE INTRA-VENTRICULAR PRESSURE" - HOW DID YOU DETECT THAT INTRA-VENTRICULAR PRESSURE OF PATIENT INCREASE? "BILATERAL MYDRIASIS" - DID THE INCIDENT INCREASE THE PATIENT'S CARE TIME? "THE INCIDENT IS RESPONSIBLE FOR THE PATIENT'S DEATH" ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE PROVIDED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287545 CERELINK ICP PROBE 1L M BOLT ICP MICRSOSENSORS - CERELINK GWM INTEGRA LIFESCIENCES MANSFIELD 6987347 10381780520889

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Death