BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA INTRATHECAL CATHETER

    MDR report key: 4899579 · Received July 8, 2015

    Report

    Report Number
    3006803715-2015-00044
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 8, 2015
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE CHRONIC HEADACHES A FEW WEEKS AFTER IMPLANT WHICH LED THE PHYSICIAN TO SUSPECT A CEREBROSPINAL FLUID (CSF) LEAK. DURING A FOLLOW UP APPOINTMENT ON (B)(6) 2015, FLUID WAS DRAINED FROM THE MIDLINE INCISION AND THE PUMP POCKET AND WAS DETERMINED TO BE RELATED TO A SEROMA AND NOT A CSF LEAK. IT WAS CONCLUDED THAT THE HEADACHES WERE UNRELATED TO THE PRODUCT AND THE PATIENT HAD SINCE CONTINUED WITH THE PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442383 PROMETRA INTRATHECAL CATHETER IMPLANTABLE INTRATHECAL CATHETER LKK FLOWONIX MEDICAL, INC 11823 20269

    Patients

    Seq Age Sex Outcome Treatment
    1 Other