BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER

    MDR report key: 3894398 · Received June 25, 2014

    Report

    Report Number
    2021898-2014-00212
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    October 29, 2013
    Report Date
    May 26, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K802100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS SHOWED NO ANOMALIES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT WAS CONNECTED TO THE DRAINAGE DEVICE FOLLOWING A CEREBRAL HEMORRHAGE IN (B)(6) 2013. ACCORDING TO THE REPORT, THE PATIENT¿S OVERALL STATUS WAS OKAY AND FLUID WAS FLOWING THROUGH THE DEVICE. THE REPORT STATE THAT THE PHYSICIAN CLOSED THE VALVE RESULTING IN THE PATIENT EXPERIENCING HEADACHE, INCREASED BP, AND WAS FRETFUL, BUT THAT THE PATIENT¿S CONDITION IMPROVED WHEN THE PHYSICIAN OPENED THE VALVE. ACCORDING TO THE REPORT, THE PHYSICIAN DID A LUMBAR DRAINAGE SURGERY WITH THE EDM SYSTEM, AND REMOVED THE DRAINAGE FROM THE PATIENT¿S HEAD THEN OBSERVED. THE REPORT STATES THAT ON (B)(6) 2013, THE PHYSICIAN FOUND THE NUCLEATED CELL OF CEREBROSPINAL FLUID TO BE 1,900,000,000/L SUGGESTING THAT THERE WAS AN INTRACRANIAL INFECTION. ACCORDING TO THE REPORT, THE PHYSICIAN TREATED THE PATIENT VANCOMYCIN BY INTRATHECAL INJECTION AND CHLORAMPHENICOL BY INTRAVENOUS INJECTION, AND THAT THE PATIENT GOT BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370803 EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 12330422

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention