BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN INFUSION PUMP

    MDR report key: 3062887 · Received April 17, 2013

    Report

    Report Number
    3007566237-2013-01319
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT HAD HER INTRATHECAL TRIALS, THEY DID TWO BLOOD PATCHES ON HER BECAUSE SHE HAD A CEREBROSPINAL FLUID (CSF) LEAK AFTER THE TRIAL. THE DRUG USED FOR THE TRIALS WAS NOT SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164494 UNKNOWN INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_CATH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention