BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3043495 · Received April 9, 2013

    Report

    Report Number
    3007566237-2013-01161
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 11, 2013
    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

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT "WENT INTO COMA" WHICH RESULTED IN HOSPITALIZATION ON AN UNSPECIFIED DATE. THE PATIENT "WAS VENTILATED AND PERFORMED HEMODIALYSIS." THE REASON FOR THOSE TREATMENTS WAS NOT REPORTED. IT WAS NOTED "IN THE FURTHER COURSE, HE EXPERIENCED PNEUMONIA," ON AN UNSPECIFIED DATE. ON (B)(6) 2013 HE WAS TRANSFERRED TO INTENSIVE CARE UNIT, AND "IN THE MEANTIME HIS CONDITION IMPROVED," IT WAS UNCLEAR WHAT WAS MEANT BY THIS. THE PHYSICIAN "SUSPECTED REBOUND EFFECT, BUT COULD NOT EXCLUDE ALCOHOL CONSUMPTION." IT WAS ALSO NOTED THE INFORMATION ON A DOSE OF LIORESAL WAS "AMBIGUOUS, BECAUSE FROM ONE SIDE THE PHYSICIAN RECEIVED INFORMATION THAT A DOSE WAS SIGNIFICANTLY REDUCED BUT AT THE SAME TIME THE PATIENT STATED THAT IT WAS PLANNED TO INCREASE THE DOSE." ACTION TAKEN WITH THE PUMP WAS NOT REPORTED. THE EVENT WAS CONSIDERED SERIOUS, OUTCOME OF EVENT WAS REPORTED AS "CONDITION IMPROVING." EVENT CAUSALITY WAS NOT REPORTED. THE DEVICE SYSTEM WAS USED TO INFUSE LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147607 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| L