BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 6087412 · Received November 8, 2016

    Report

    Report Number
    3007566237-2016-03963
    Event Type
    Injury
    Date Received
    November 8, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THE PATIENT HAD TO HAVE THEIR PUMP REPLACED. THE CAUSE WAS NOTED AS A BATTERY PROBLEM. IT WAS NOTED THE PATIENT HAD BEEN THROWN INTO WITHDRAWAL WITHOUT WARNING. THE EVENT DATE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737244 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention