BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERELINK ICP PROBE BASIC KIT

    MDR report key: 16230476 · Received January 23, 2023

    Report

    Report Number
    3013886523-2023-00007
    Event Type
    Injury
    Date Received
    January 23, 2023
    Date of Event
    December 12, 2022
    Report Date
    March 16, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    UDI-DI
    10381780520672
    PMA / PMN Number
    K173192
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H10 THE CERELINK SENSOR WAS NOT RETURNED FOR EVALUATION; HOWEVER, A PICTURE WAS PROVIDED BY THE CUSTOMER: DHR - LOT 6162670 MET SPECIFICATIONS WHEN RELEASED FAILURE ANALYSIS - BASED ON THE PICTURE PROVIDED BY CUSTOMER, WE CAN CONFIRM THE ISSUE REPORTED BY CUSTOMER: PRESSURE DROPPED TO NEGATIVE VALUE. ROOT CAUSE - THE POSSIBLE ROOT CAUSE FOR THIS ISSUE REPORTED BY THE CUSTOMER, AND CONFIRMED WITH THE PICTURE PROVIDED, COULD BE DUE TO EXCESSIVE PRESSURE APPLIED TO PRODUCT.

    Additional Manufacturer Narrative · 0

    THE CERELINK ICP (ID 826850) WAS NOT RETURNED FOR EVALUATION, LOT NUMBER INFORMATION HAS BEEN PROVIDED, THEREFORE DHR WAS REVIEWED THE LOT NUMBER MET SPECIFICATIONS WHEN RELEASED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A PROBABLE ROOT CAUSE WAS EXCESSIVE PRESSURE APPLIED TO PRODUCT. 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

    N/A

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    THIS IS 1 OF 2 REPORTS (SAME PRODUCT ID, SAME FAILURE, DIFFERENT PATIENTS). LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00008. A FACILITY REPORTED A MICROSENSOR (ID 826850) DROPPED THE PRESSURE TO -35MMHG. THE PATIENT WAS STABLE WITH AN ICP 8-10 MMHG AND WASN'T MOVED OR GIVEN ANY MEDICATION. THE MICROSENSOR WAS IMPLANTED ON (B)(6) 2022 AND WAS REMOVED ON (B)(6) 2022. BASED ON INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCE ANY SIGNS AND SYMPTOMS. PATIENT OUTCOME IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301818 CERELINK ICP PROBE BASIC KIT ICP MICRSOSENSORS - CERELINK GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 826850 6162670 10381780520672

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown