BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3203498 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01105
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    July 6, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. HEALTHCARE PROVIDER REPORTED PATIENT MISSED THEIR PUMP REFILL APPOINTMENT TWICE AND THE PUMP RESERVOIR HAS BEEN DRY FOR APPROXIMATELY 10 DAYS. THE PATIENT HAD CANCELLED HER APPOINTMENT TWICE AND IT SEEMED THERE WERE NOT ISSUES ON THE PART OF THE PATIENT. IT WAS REPORTED THE PATIENT WAS DOING FINE AND MIGHT BE ON PO PAIN MEDICATION. HCP ALSO STATED HE THOUGHT THE PUMP WAS RUNNING AT A LOW INFUSION RATE. HCP DID NOT KNOW THE PATIENT¿S NAME, SYSTEM DRUG OR ANY OTHER DETAILS AS THEY WERE NOT IN THE OFFICE AT THE TIME OF THE REPORTED INFORMATION. LATER ON HCP REPORTED THE PATIENT CAME IN FOR REFILL, THE REFILL WENT WELL AND THERE WERE NO FURTHER ISSUES. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302805 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1