BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICP SENSOR

    MDR report key: 5262096 · Received December 2, 2015

    Report

    Report Number
    1226348-2015-10719
    Event Type
    Injury
    Date Received
    December 2, 2015
    Date of Event
    June 24, 2015
    Product Code
    GWM
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GTIN: UNKNOWN. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE "COMPARISON OF PULSATILE AND STATIC PRESSURES WITHIN THE INTRACRANIAL AND LUMBAR COMPARTMENTS IN PATIENTS WITH CHIARI MALFORMATION TYPE 1: A PROSPECTIVE OBSERVATIONAL STUDY" PUBLISHED ACTA NEUROCHIR (2015) 157:1411 - 1423, DOI 10.1007/S00701-015-2465-X. IT WAS REPORTED THAT ONE PATIENT HAD A VENOUS BRAIN INFARCTION CHARACTERIZED BY EPILEPTIC SEIZURE. IN CHIARI MALFORMATION TYPE 1 (CMI), THE OBSTRUCTION OF CEREBROSPINAL FLUID (CSF) FLOW THROUGH THE FORAMEN MAGNUM IS BELIEVED TO CAUSE ALTERATIONS OF INTRACRANIAL PRESSURE (ICP) PULSATIONS. FORAMEN MAGNUM DECOMPRESSION (FMD) IS THEREFORE CONSIDERED A TREATMENT OF CHOICE. DURING THE STUDY PERIOD BETWEEN MAY 2011 AND DECEMBER 2013, 26 CONSECUTIVE PATIENTS WERE ENROLLED IN THE STUDY: 15 WOMEN AND 11 MEN, MEDIAN AGE 35 YEARS (RANGE 22 - 72 YEARS). IN LOCAL ANESTHESIA AND THROUGH A CRANIAL BURR HOLE PLACED IN FRONT OF THE CORONARY SUTURE, TYPICALLY ON THE RIGHT SIDE, THE ICP SENSOR (MICROSENSOR; CODMAN, JOHNSON & JOHNSON, (B)(4), USA) WAS PLACED 1-2 CM INTO THE BRAIN PARENCHYMA. IN THE SAME SESSION AND WITH THE PATIENT IN THE LATERAL POSITION, A STANDARD LUMBAR SPINAL PUNCTURE WAS THEN PERFORMED, TAKING CARE THAT MINIMUM POSSIBLE AMOUNT OF THE CSF WAS TAPPED, NOT TO INFLUENCE THE PRESSURE MEASUREMENT. AN INTRATHECAL CATHETER WAS LEFT IN PLACE; BOTH ICP SENSOR AND SPINAL CATHETER WERE CALIBRATED IN A STANDARD MANNER AND CONNECTED TO THE TRANSDUCER UPON PATIENT'S RETURN TO THE WARD. THE SIMULTANEOUS MONITORING OF INTRACRANIAL AND LUMBAR PRESSURE CONTINUED OVERNIGHT, TYPICALLY LASTING 16-24 HOURS. RECORDING WAS THEN TERMINATED THE FOLLOWING DAY AND BOTH ICP SENSOR AND LUMBAR CATHETER WERE WITHDRAWN. THERE WERE NO SERIOUS COMPLICATIONS TO PRESSURE MONITORING. NEVERTHELESS, WE EXPERIENCED ONE CASE OF SMALL VENOUS BRAIN INFARCTION AT THE INSERTION SITE OF ICP SENSOR; THIS PRESENTED WITH SOLITARY EPILEPTIC SEIZURE, BUT THE PATIENT RECOVERED COMPLETELY WITHOUT ANY CLINICAL SEQUELAE. AT THE TIME OF COMPLAINT ENTRY THERE IS NO CATALOGUE OR LOT NUMBER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790793 ICP SENSOR DEVICE, INTRACRANIAL PRESSURE MONITORING GWM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention