BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3103374 · Received May 9, 2013

    Report

    Report Number
    3007566237-2013-01575
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    September 17, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE SYSTEM DELIVERED MORPHINE AND THE CAUSE OF THE EVENT WAS REPORTED AS ¿SURGERY¿ AND THE EVENT WAS NOT ATTRIBUTED TO THE DEVICE SYSTEM, PROGRAMMER OR DRUG EFFECTS.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PUMP HAD BEEN FILLED WITH SALINE GREATER THAN ONE YEAR. THE PATIENT WANTED THE PUMP REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD CELLULITIS TWICE WHILE THE DEVICE WAS IMPLANTED, RIGHT AFTER SURGERY IN 2005. IT WAS ALSO STATED THAT THE PATIENT HAD LYMPHEDEMA, THOUGH IT WAS UNCLEAR IF IT WAS RELATED TO THE CELLULITIS. IT WAS REPORTED THAT THE PUMP FORMERLY CONTAINED MORPHINE, THOUGH IT WAS UNCLEAR IF THIS DATED BACK TO 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203153 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention