BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EVD CATHETER

    MDR report key: 6048908 · Received October 21, 2016

    Report

    Report Number
    2021898-2016-00389
    Event Type
    Injury
    Date Received
    October 21, 2016
    Report Date
    September 21, 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: TREATMENT OF SEVERE INTRAVENTRICULAR HEMORRHAGE BY EXTERNAL VENTRICULAR DRAINAGE AND IMPLANTING OF OMMAYA RESERVOIR CHEN XIAO-DONG, XIA YING, CHEN WEI-MING, YAN SHAN, LI YOU-JUN CHINA JOURNAL OF MODERN MEDICINE 2013 23(22):89-91 1005-8982(2013)22-0089-03.

    Description of Event or Problem · 1

    MEDTRONIC NEUROSURGERY IDENTIFIED THE FOLLOWING INFORMATION UPON REVIEW OF SCIENTIFIC LITERATURE: THE ARTICLE STATED THAT EXTERNAL VENTRICULAR DRAINAGE WAS PERFORMED IN 43 CASES WITH SEVERE INTERVENTRICULAR HEMORRHAGE. ACCORDING TO THE ARTICLE, AFTER 5-7 DAYS OF DRAINAGE, THE EVD WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. THE ARTICLE STATED THAT ONE PATIENT EXPERIENCED AN INTRACRANIAL INFECTION, CONTROLLED WITH ANTIBIOTICS, ONE PATIENT EXPERIENCED CEREBRAL ARTERIOVENOUS MALFORMATIONS AND EMBOLISM TREATMENT WAS ADMINISTERED. THE ARTICLE STATED THAT THREE PATIENTS EXPERIENCED CONCURRENT HYDROCEPHALUS AND FOUR PATIENTS HAD DIED. THE ARTICLE DID NOT SPECIFY THAT THE DEVICE CAUSED OR CONTRIBUTED TO THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699587 UNKNOWN EVD CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R