BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERELINK ICP PROBE 1L M BOLT

    MDR report key: 17925084 · Received October 12, 2023

    Report

    Report Number
    3013886523-2023-00353
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    September 26, 2023
    Report Date
    December 1, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    UDI-DI
    10381780520889
    PMA / PMN Number
    K153347
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CERELINK SENSOR (ID 826851) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - PRODUCT 826851 FOR LOT NUMBER 7034031 (SERIAL NUMBER (B)(6), AND THE LOT MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - BASED ON THE ANALYSIS AND INVESTIGATION, THE ISSUE OF THE COMPLAINT HAS BEEN CONFIRMED. CATHETER MATERIAL STRETCHED 12.5CM FROM CONNECTOR. CATHETER INTERNAL WIRES ARE BROKEN AT STRETCHED AREA. CERELINK MONITOR NOT ACCEPTABLE; ICP EXPRESS READ "NO TRANSDUCER DETECTED". ROOT CAUSE ANALYSIS - COULD BE DETERMINED AS A MISHANDLING OF THE CATHETER.

    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

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED A MICROSENSOR (ID 626638US) WAS IMPLANTED AND WORKED CORRECTLY FOR ABOUT SIX HOURS. THE PATIENT SENSOR WAS DISCONNECTED, HOWEVER, WHEN THE MONITOR WAS RECONNECTED THE SENSOR DID NOT WORK ANY LONGER. ALL KNOWN TROUBLE SHOOTING TECHNIQUES WERE USED, BUT NOTHING WORKED TO CORRECT THE PROBLEM. THE PATIENT WAS ROLLED AND THE MICROSENSOR STOPPED WORKING. THE TWO EXPRESS MONITOR READS ¿NO TRANSDUCER DETECTED¿ INDICATING THERE WAS NO SIGNAL FROM THE IMPLANT. THE TWO GREY PATIENT CABLE WAS REPLACED AS WELL AS THE NEW MONITOR INTRODUCED, ALL WITH SAME RESULT; NO TRANSDUCER DETECTED. THEREFORE, THE SENSOR WAS REMOVED ON (B)(6) 202 DUE TO FAILURE. THE MICROSENSOR WAS USED FOR HALF A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311688 CERELINK ICP PROBE 1L M BOLT ICP MICRSOSENSORS - CERELINK GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 7034031 10381780520889

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CODMAN GREY PATIENT CABLE X2| CODMAN ICP EXPRESS X2