BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICP SENSOR

    MDR report key: 5261967 · Received December 2, 2015

    Report

    Report Number
    1226348-2015-10718
    Event Type
    Injury
    Date Received
    December 2, 2015
    Date of Event
    April 14, 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 ¿CHARACTERISTICS OF INTRACRANIAL PRESSURE (ICP) WAVES AND ICP IN CHILDREN WITH TREATMENT-RESPONSIVE HYDROCEPHALUS¿ PUBLISHED ACTA NEUROCHIR (2015) 157:1003¿1014, DOI 10.1007/S00701-015-2410-Z, IT WAS REPORTED THAT THREE PATIENT SUFFERED DEVICE RELATED COMPLICATIONS, SPECIFICALLY TWO WOUND INFECTIONS AND ONE SURGICAL AREA HEMORRHAGE. THE AIM OF THE PRESENT WORK WAS TO CHARACTERIZE THE ICP WAVES/ICP IN CHILDREN WITH EITHER COMMUNICATING OR NON-COMMUNICATING HYDROCEPHALUS WHO IMPROVED CLINICALLY AFTER SURGERY. CHILDREN WITH EITHER COMMUNICATING OR NON-COMMUNICATING HYDROCEPHALUS IMPROVING CLINICALLY AFTER SURGERY PRESENTED WITH ELEVATED MWA AND MEAN ICP. IN PARTICULAR, THE LEVELS OF MWA WERE RAISED TO A MAGNITUDE SEEN WHEN INTRACRANIAL COMPLIANCE IS IMPAIRED. HENCE, THE PRESENT OBSERVATIONS MAY SUPPORT THE IDEA THAT IMPROVEMENT OF INTRACRANIAL COMPLIANCE CAN BE AN IMPORTANT MECHANISM BY WHICH SHUNTS WORK IN PEDIATRIC HYDROCEPHALUS. THE PATIENT MATERIAL INCLUDES ALL CHILDREN WITH COMMUNICATING OR NON-COMMUNICATING HYDROCEPHALUS AND NO PREVIOUS SURGICAL TREATMENT THAT UNDERWENT DIAGNOSTIC ICP WAVE/ICP MONITORING DURING THE PERIOD 2002¿2011. THE MONITORING WAS DONE AS PART OF THE PREOPERATIVE DECISION-MAKING. THE INSTITUTIONAL ROUTINE FOR ICP MONITORING HAS BEEN DESCRIBED PREVIOUSLY [13]. IN SHORT, UNDER LOCAL ANESTHESIA OR GENERAL ANESTHESIA, A BURR HOLE WAS MADE IN THE SKULL. AN UNIDENTIFIED CODMAN ICP MICRO-SENSOR (CODMAN MICROSENSOR, CODMAN MICRO SENSOR, JOHNSON AND JOHNSON, (B)(4), USA) WAS ZEROED AGAINST THE ATMOSPHERIC PRESSURE AND PLACED 1¿2 CM INTO THE BRAIN PARENCHYMA VIA A MINOR OPENING IN THE DURA. THE PATIENT WAS THEN RETURNED TO THE WARD AND THE ICP MONITORING STARTED AND CONTINUED UNTIL THE NEXT DAY. DURING THE PERIOD 2002¿2011, 58 CHILDREN WHO HAD NOT PREVIOUSLY BEEN TREATED SURGICALLY UNDERWENT DIAGNOSTIC ICP WAVE/ICP MONITORING AS PART OF PREOPERATIVE ASSESSMENT FOR HYDROCEPHALUS. FOLLOWING DIAGNOSTIC MONITORING, 31 PATIENTS (53 %) UNDERWENT SHUNT SURGERY (SURGERY GROUP), WHILE 27(47 %) CHILDREN WERE MANAGED WITHOUT SURGERY (NON-SURGERY GROUP).COMPLICATIONS TO ICP MONITORING WERE OBSERVED IN 3/58 PATIENTS (5.2 %). THESE CONSISTED OF TWO CASES WITH WOUND INFECTIONS TREATED WITH ANTIBIOTICS. ONE CHILD EXPERIENCED SIGNIFICANT PERIOPERATIVE BLEEDING FROM THE WOUND (NOT INTRACRANIAL) AND NEEDED A BLOOD TRANSFUSION, ALTHOUGH WITHOUT ANY POSTOPERATIVE HEMATOMAS OR DETECTABLE SEQUELAE. AT THE TIME OF COMPLAINT ENTRY THERE IS NO CATALOGUE OR LOT NUMBER INFORMATION AVAILABLE FOR THE COMPLAINT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790444 ICP SENSOR DEVICE, INTRACRANIAL PRESSURE MONITORING GWM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention