BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOMED

    MDR report key: 3013220 · Received March 20, 2013

    Report

    Report Number
    3007566237-2013-00841
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P990034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    VOLUME DISCREPANCY OCCURRED. THE PATIENT HAD NOT GOOD BUT CONSISTENT EFFICACY, FOR THE PAST SEVEN YEARS DESPITE VOLUME DISCREPANCY (ACTUAL RESIDUAL VOLUME 3-5CC GREATER THAN EXPECTED RESIDUAL VOLUME) AT ROUTINE REFILL. THE PATIENT REQUESTED A CATHETER DYE STUDY. THE PHYSICIAN INJECTED 10CC OF CONTRAST DYE, WITHOUT DIFFICULTY, IN CATHETER ACCESS PORT (CAP) AND DID NOT FIRST WITHDRAW CATHETER CONTENTS. VIEWED IN "REAL TIME" "MYELOGRAM," THE HCP COULD VIEW THE CATHETER, THE CONNECTION AND THE PUMP "ALL THE WAY TO SPINE, WHICH THE CATHETER WAS AT L1." THE HCP COULD "SEE EVERYTHING WELL," AND THAT THERE WAS "NO LEAK IN THE WHILE SYSTEM," THE "PROBLEM" WAS THAT THE HCP COULDN'T SEE CONTRAST COMING OUT FROM THE SPINAL END, "JUST NOTHING." A "DIFFERENT X-RAY" WAS DONE TO CHECK FOR CONTRAST "SOMEWHERE BEHIND THE PUMP," NO CONTRAST WAS FOUND. IT WAS ALSO NOTED THAT WHEN THE HCP WAS "NOT DOING ANYTHING FROM THE INJECTION," THERE WAS BACK FLOW OF "CLEAR FLUID" INTO THE SYRINGE. THE HCP CLAMPED THE SYRINGE AT 2CC OF BACKFLOW. IT WAS NOT KNOWN WHAT THE BACKFLOW FLUID WAS, IF IT WAS CONTRAST, MEDICATION OR CEREBROSPINAL FLUID. THE CAUSE OF THE BACKFLOW WAS ALSO UNKNOWN. THE HCP EXPRESSED CONCERN THAN THE CONTRAST BACKED UP INTO THE PUMP IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS RELATED TO THIS EVENT. THE DEVICE SYSTEM WAS USED TO INFUSE BUPIVACAINE AND HYDROMORPHONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116093 ISOMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8472

    Patients

    Seq Age Sex Outcome Treatment
    1