BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 7068899 · Received November 29, 2017

    Report

    Report Number
    3010079947-2017-00170
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    September 22, 2017
    Report Date
    October 30, 2017
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED FOR COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS SUBJECTED TO VISUAL EXTERNAL AND INTERNAL INSPECTION, AS WELL AS FUNCTIONAL, ELECTRICAL, AND FLOW TESTING. THE EVALUATION DETERMINED THAT THE ISSUE WAS LIKELY CAUSED BY A CHEMICAL INTERACTION OCCURRING BETWEEN AN INTERNAL COMPONENT AND THE DRUG. THE DRUG, VALPROATE, WAS USED DURING A CLINICAL INVESTIGATION WITH THE PUMP. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED EVENT WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGICAL INTERVENTION WAS TAKEN TO EXPLANT THE PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VOLUME OF UNDELIVERED DRUG REMAINING IN THE DRUG RESERVOIR WAS GREATER THAN THE EXPECTED VOLUME BASED UPON THE PROGRAMMED INFUSION RATE ON FOUR OCCASIONS. PUMP THERAPY IS INTENDED TO TREAT SYMPTOMS ASSOCIATED WITH EPILEPSY WITH 80 MG VALPROATE PER DAY WITH CITRIC ACID AND WITH A DRUG CONCENTRATION OF 150 MG PER ML. THE PATIENT EXPERIENCED INCREASED SEIZURES DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847443 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC. 13827 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention