BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDM VENTRICULAR CATHETER, 35 CM

    MDR report key: 6677872 · Received June 29, 2017

    Report

    Report Number
    2021898-2017-00354
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    June 1, 2017
    Report Date
    June 2, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    UDI-DI
    00643169498211
    PMA / PMN Number
    K981046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE LEAK OCCURRED WITH THE DRAINAGE SYSTEM. PLEASE REFER TO MANUFACTURER REPORT # 2021898-2017-00355. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE LEAK OCCURRED WITH THE DRAINAGE SYSTEM. PLEASE REFER TO MANUFACTURER REPORT # 2021898-2017-00355. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AFTER A VENTRICULAR DRAINAGE SURGERY, IN THE COURSE OF OBSERVING THE PATIENT'S CONDITION, THE PHYSICIAN FOUND THAT THERE WAS GAS IN THE PATIENT'S LATERAL VENTRICLE DUE TO THE DRAIN PIPE LEAKING ON (B)(6) 2017. ACCORDING TO THE REPORT, THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER DEVICE. REPORTEDLY, THE PATIENT'S STATUS AT THE TIME OF THE REPORT ALIVE-NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457387 EDM VENTRICULAR CATHETER, 35 CM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY E11056 00643169498211

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R