BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSION PUMP, UNKNOWN

    MDR report key: 3955499 · Received July 24, 2014

    Report

    Report Number
    3007566237-2014-02071
    Event Type
    Death
    Date Received
    July 24, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CALLER HAD DONE SOME RESEARCH AND HAD SEEN "ISSUES WITH THE PAIN PUMP, DEATH, ETC" ONLINE. THE PUMP WAS INTENDED TO INFUSE AN UNKNOWN DRUG. IT WAS LATER NOTED THAT THE REPORTER DID NOT HAVE THE INFORMATION REGARDING WHICH WEBSITE, ARTICLE, SEARCH ENGINE, OR DATE ACCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433756 INFUSION PUMP, UNKNOWN PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death