BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 4081116 · Received August 29, 2014

    Report

    Report Number
    3006803715-2014-00024
    Event Type
    Injury
    Date Received
    August 29, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    FLOWONIX MEDICAL INC.
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN BELIEVED THAT AN INFECTION MAY HAVE BEEN CAUSED BY THE PUMP DUE TO THE PATIENT'S IMPLANT SURGERY. THE PUMP WAS EXPLANTED FROM THE PATIENT. AFTER THE PUMP WAS EXPLANTED THE PHYSICIAN DETERMINED THAT THE PUMP WAS NOT THE CAUSE OF THE INFECTION. THE PATIENT'S UNDERLYING DISEASE (CANCER) WAS DETERMINED TO BE THE CAUSE OF THE INFECTION. IT WAS ALSO REPORTED THAT THE PHYSICIAN BELIEVED THAT THE EXPLANT MAY NOT BE NECESSARY, BUT A DECISION WAS MADE TO EXPLANT THE PUMP AS A PRECAUTION. THE PUMP WAS DISCARDED AFTER THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527642 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL INC. 11827

    Patients

    Seq Age Sex Outcome Treatment
    1 Other