BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EVD CATHETER

    MDR report key: 6048913 · Received October 21, 2016

    Report

    Report Number
    2021898-2016-00390
    Event Type
    Injury
    Date Received
    October 21, 2016
    Report Date
    September 23, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THESE EVENTS WERE IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. FOLLOW UP ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, BUT HAVE BEEN UNSUCCESSFUL. THE EVENT REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE PRODUCTS WERE UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBERS WERE PROVIDED. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE. LITERATURE ARTICLE: EXTERNAL VENTRICULAR DRAINAGE THROUGH LATERAL PUNCTURE UNDER INTRACRANIAL PRESSURE MONITORING FOR TREATMENT OF INTRAVENTRICULAR HEMORRHAGE XU F, ZHANG L, YANG Z, WANG S, SONG Q, XU X, WANG Z, GU Y, LAN W, QIAN L, DONG X ZHEJIANG MEDICAL JOURNAL 2015 8:664-666; 670. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC NEUROSURGERY IDENTIFIED THE FOLLOWING INFORMATION UPON REVIEW OF SCIENTIFIC LITERATURE: THE ARTICLE STATED THAT 126 PATIENTS WITH INTERVENTRICULAR HEMORRHAGE UNDERWENT AN EXTERNAL VENTRICULAR DRAINAGE THROUGH LATERAL VENTRICLE PUNCTURE UNDER INTRACRANIAL PRESSURE MONITORING. ACCORDING TO THE ARTICLE, THE RATE OF POSTOPERATIVE RESULTS WERE RECURRENT BLEEDING IN 26 PATIENTS, ACUTE RENAL IMPAIRMENT IN 37 PATIENTS, AND AN INTRACRANIAL INFECTION IN 16 PATIENTS. THE ARTICLE STATED THAT PATIENTS RECEIVED 0.95 G/KG-DAY MANNITOL OR 1.76 G/KG-DAY OF MANNITOL. THE ARTICLE DID NOT SPECIFY IF THE DEVICE CAUSED OR CONTRIBUTED TO THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698438 UNKNOWN EVD CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R