BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 6053892 · Received October 25, 2016

    Report

    Report Number
    3007566237-2016-03703
    Event Type
    Death
    Date Received
    October 25, 2016
    Report Date
    October 25, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A LEGAL FIRM REGARDING A PATIENT RECEIVING UNKNOWN BACLOFEN AT UNKNOWN CONCENTRATION/DOSE VIA AN IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THE PATIENT HAD A BACLOFEN PUMP. THE PUMP WAS MISMANAGED WITH HIGH CONCENTRATION COCKTAIL. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER). PATIENT WAS DECEASED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705821 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death