BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLM INTRACRANIAL PRESSURE

    MDR report key: 1484390 · Received September 23, 2009

    Report

    Report Number
    2023988-2009-00030
    Event Type
    Death
    Date Received
    September 23, 2009
    Date of Event
    September 6, 2009
    Report Date
    September 23, 2009
    Manufacturer
    INTEGRA NEUROSCIENCES SD
    Product Code
    GWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED, BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    ON 09/14/2009, THE REPORTER CALLED TO NOTIFY INTEGRA LIFE SCIENCES OF AN INCIDENT INVOLVING A PT UNDER HIS TREATMENT. THE INCIDENT INVOLVED A FEMALE PT DIAGNOSED WITH A CHIARI MALFORMATION WHO HAD BEEN EXPERIENCING SEVERE HEADACHES. INITIALLY, THE PT REC'D AN IMPLANTED VENTRICULAR PRESSURE SHUNT AND LATER REC'D A LUMBAR DRAIN. FINALLY, PLACEMENT OF THE CAMINO CATHETER TO MONITOR INTRACRANIAL PRESSURE. THE INTRACRANIAL PRESSURE WAS LOW, WHEN THE HEALTHCARE PROFESSIONAL THOUGHT SHE MAY BE OVERDRAINING. THE VENTRICULAR PRESSURE TUBING WAS CUT. X-RAYS WERE THEN TAKEN AND THEN THEY LIGATED THE LUMBAR PRESSURE TUBING. THE INTRACRANIAL PRESSURE READINGS WERE IN THE TEENS, BUT ONE TIME, THE VALUE JUMPED TO 80MMHG. PT WAS GIVEN MORPHINE IN A PCA FOR THE SEVERE HEADACHES. PT WENT INTO RESPIRATORY ARREST AT 4:15 ON THE DAY OF EVENT IN 2009, GIVEN NARCAN, BAGGED WHEN THE DOCTOR NOTICED THAT THE CATHETER WAS NOT POSITIONED CORRECTLY BY THE "RED DOTS". DR DID NOT ORIGINALLY INSERT THE CATHETER, BUT ONCE IT WAS NOTICED IT WAS NOT PROPERLY PLACED, HE COMPLETELY REMOVED THE CATHETER AND REINSERTED. THE INTRACRANIAL PRESSURE RESULTS WERE THEN CONSISTENTLY 80-90MMHG. PT EXPIRED SHORTLY THEREAFTER IN THE SAME DAY. THE REPORTER DID NOT CONSIDER THE DEVICE TO HAVE CONTRIBUTED TO THE DEATH OF THE PT. ADD'L CLINICAL INFO HAS BEEN REQUESTED FROM THE REPORTING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLM INTRACRANIAL PRESSURE NA GWM INTEGRA NEUROSCIENCES SD

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death