BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 6107407 · Received November 16, 2016

    Report

    Report Number
    3006803715-2016-00181
    Event Type
    Death
    Date Received
    November 16, 2016
    Date of Event
    August 17, 2016
    Report Date
    October 17, 2016
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED WITH ADDITIONAL INFORMATION. CORRECTED G8 PER REQUEST OF FDA, DATED 10/SEP/2020. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S CAUSE OF DEATH IS UNKNOWN BY THE PATIENT'S PAIN MANAGEMENT FACILITY. HOWEVER, THE PATIENT'S PHYSICIAN DOES NOT BELIEVE THAT THE PUMP WAS CAUSALLY RELATED TO THE PATIENT'S DEATH, AND DOES NOT BELIEVE THERE WERE ANY ISSUES WITH THE PUMP. PUMP THERAPY WAS INTENDED TO TREAT PAIN DUE TO FAILED BACK SURGERY SYNDROME AND CERVICALGIA WITH BUPIVACAINE, BACLOFEN, AND MORPHINE. THE MORPHINE DOSAGE WAS 1.7 MG/DAY, AND THE DAILY DOSE FOR BUPIVACAINE AND BACLOFEN ARE UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2016. THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758954 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 13827 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H