BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 7076926 · Received December 1, 2017

    Report

    Report Number
    3010079947-2017-00171
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    November 11, 2016
    Report Date
    November 1, 2017
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO EPISODES OF LOSS OF CONSCIOUSNESS, SEVERE BACK PAIN, VOMITING AND DIARRHEA. THE PHYSICIAN DETERMINED THE PUMP MALFUNCTIONED (SIDE PORT APPEARED TO BE TURNING OFF THE PUMP ONCE IT IS USED) AND THEREFORE DECIDED TO EXPLANT THE PUMP. THE PATIENT CLAIMS THE DIAGNOSIS IS FULL BLOWN OPIOID WITHDRAWAL CAUSING A HEART ATTACK AND SEVERE MEMORY LOSS ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856573 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 13827

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R