BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC INDURA

    MDR report key: 205902 · Received September 8, 1998

    Report

    Report Number
    205902
    Event Type
    Other
    Date Received
    September 8, 1998
    Date of Event
    September 2, 1998
    Report Date
    September 8, 1998
    Manufacturer
    MEDTRONIC INC DRUG ADMINISTRATION SYS
    Product Code
    MDV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED HEADACHE AND POCKET OF FLUID IN BACK 8-9 DAYS PRIOR TO SURGICAL EXPLORATION OF L4-5 LAMINECTOMY SITE. ON EXAMINATION THE PTS INTRATHECAL CATHETER WAS FOUND TO BE BROKEN IN HALF. A CONNECTOR WAS USED TO RECONNECT THE BROKEN ENDS. THE CATHETER WAS SLID BACK INTO POSITION AND THE WOUND WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INDURA Implant CATHETER MDV MEDTRONIC INC DRUG ADMINISTRATION SYS 8703W 5.6UVIN L 43274

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other MEDTRONIC INDURA CATHETER AND| MEDTRONIC SYNCHROMED PUMP 8617 IMPLANTED