BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 2961965 · Received February 14, 2013

    Report

    Report Number
    3007566237-2013-00485
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEALTHCARE PROVIDER (HCP) HAD SEVERAL INSTANCES ENCOUNTERED WHERE THERE WAS AN OCCLUSION OF THE CATHETER DUE TO A "SCHMUTZ", OR SOFT TAN MATERIAL WHICH CAN CLOG THE CATHETER. NO OTHER SPECIFIC INFORMATION WAS PROVIDED REGARDING THE MULTIPLE ENCOUNTERS. 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
    65612 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN NEURO CATHETER