BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 7050972 · Received November 21, 2017

    Report

    Report Number
    3010079947-2017-00166
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    June 12, 2017
    Report Date
    October 27, 2017
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    UDI-DI
    00810335020082
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED THAT A PATIENT HAD A PUMP POCKET REVISION 1 ½ YEARS AFTER THE INITIAL PUMP IMPLANT, TO PLACE THE PUMP DEEPER IN THE POCKET. THE PATIENT DEVELOPED A SEROMA AFTER THE PUMP POCKET REVISION AND IS REQUIRED TO HAVE THE SEROMA ASPIRATED EVERY ONE TO TWO WEEKS. SURGICAL INTERVENTION WAS TAKEN TO EXPLANT THE PUMP AND REMOVE THE SUTURE RING BECAUSE THE PHYSICIAN BELIEVED THE SHARPNESS OF THE PLASTIC RING MAY BE CAUSING THE SEROMA. HOWEVER, THE SEROMAS STILL CONTINUED TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828009 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC. 11827 00810335020082

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention