BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN MICROSENSOR

    MDR report key: 3943776 · Received July 18, 2014

    Report

    Report Number
    1226348-2014-11829
    Event Type
    Injury
    Date Received
    July 18, 2014
    Product Code
    GWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR AT THIS POINT IF THE DEVICE AND/OR LOT INFORMATION IS AVAILABLE. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF THE DEVICE IS RETURNED THE COMPLAINT WILL BE INVESTIGATED AND A FOLLOW UP REPORT WILL BE FILED. IF LOT INFORMATION DOES BECOMES AVAILABLE AND IF THE RECORD REVIEW INDICATES THAT THERE WAS A NON-CONFORMITY A FOLLOW UP REPORT WILL BE FILED. NO PRODUCT CODE WAS REPORTED THEREFORE A 510K WAS NOT PROVIDED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE ARTICLE REPORTED: DATA WERE COLLECTED FOR 88 PATIENTS WHO PRESENTED TO 2 NEUROSURGICAL DEPARTMENTS, CENTER 1 (N 48) AND CENTER 2 (N 40). THE CODMAN MICROSENSOR INTRAPARENCHYMAL PRESSURE MONITORING SYSTEM WAS INSERTED WHEN CLINICALLY INDICATED. SENSORS WERE ZEROED AGAINST ATMOSPHERIC PRESSURE (IN 10 ML OF STERILE NORMAL SALINE MEASURED IN A STANDARD CONTAINER AT A DEPTH OF 1 CM) AND INSERTED INTO THE PARENCHYMA. ICP READINGS WERE DISPLAYED USING THE CODMAN ICP EXPRESS MONITOR (CODMAN AND SHURTLEFF, INC.). THE DEVICE WAS USED IN A NORMAL CLINICAL FASHION. WHEN CLINICALLY APPROPRIATE, SENSORS WERE REMOVED FROM THE PATIENT AND IMMERSED IN NORMAL SALINE AT ATMOSPHERIC PRESSURE. THIS ZERO DRIFT READING, THE LENGTH OF TIME THAT THE SENSOR HAD BEEN IN SITU (IN HOURS), AND THE ORIGINAL INDICATION FOR THE ICP MONITORING WERE RECORDED. ICP DRIFT READINGS AND LENGTH OF TIME IN SITU WERE TESTED FOR NORMALITY USING THE SHAPIRO-WILKS TEST. NONPARAMETRIC SPEARMAN RANK CORRELATION WAS DERIVED BETWEEN ZERO DRIFT AND LENGTH OF TIME. THE STATISTICAL SIGNIFICANCE BETWEEN ZERO DRIFT SCORES IN EACH CENTER WAS ASSESSED WITH THE MANN-WHITNEY U TEST. POPULATION CHARACTERISTICS BETWEEN THE 2 CENTERS WERE COMPARED WITH THE INDEPENDENT T TEST FOR CONTINUOUS VARIABLES AND THE 2 TEST FOR CATEGORICAL VARIABLES. ANALYSIS WAS PERFORMED USING SPSS SOFTWARE (VERSION 15 FOR WINDOWS; SPSS, INC., CHICAGO, IL). ALTHOUGH LABORATORY AND CLINICAL ASSESSMENTS OF THESE MONITORING SYSTEMS HAVE SHOWN THEM TO BE LARGELY ACCURATE AND REPRODUCIBLE, THEY ARE INHERENTLY SUSCEPTIBLE TO ZERO DRIFT. THIS IS A RESULT OF AN INABILITY TO BE RECALIBRATED WITH ATMOSPHERIC PRESSURE ONCE INSERTED, THUS RESULTING IN INCREASING DRIFT OF ZERO VALUE WITH TIME. THIS TRANSLATES INTO INACCURATE PRESSURE READINGS. ZERO DRIFT DOES EXIST IN THE CODMAN ICP MONITOR, WHICH IS WELL WITHIN THE MANUFACTURER¿S LIMITS. HOWEVER, 20% OF DRIFT VALUES WERE SHOWN TO BE EXCESSIVE. IN APPROXIMATELY HALF OF THESE CASES, MANAGEMENT MIGHT HAVE BEEN DIFFERENT IF DRIFT HAD BEEN ACCOUNTED FOR. THERE WAS A POSITIVE CORRELATION WITH TIME. THE DIFFERENCES SEEN BETWEEN THE 2 CENTERS WERE LIKELY TO BE DIFFERENCES IN DRIFT DISTRIBUTION AND DIRECTION RATHER THAN ABSOLUTE MAGNITUDE. THIS STUDY HIGHLIGHTS THAT, ALTHOUGH ICP READINGS CONTRIBUTE SIGNIFICANTLY TO THE MANAGEMENT OF NEUROSURGICAL PATIENTS, THEY SHOULD BE INTERPRETED CAREFULLY AND IN CONJUNCTION WITH CLINICAL AND RADIOLOGICAL ASSESSMENT OF PATIENTS. LIMITED EMPHASIS SHOULD BE PLACED ON ABSOLUTE VALUES, WITH MORE EMPHASIS ON TRENDS IN ICP READINGS IN A PARTICULAR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421668 CODMAN MICROSENSOR DEVICE, INTRACRANIAL PRESSURE MONITORING GWM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention