BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 12060064 · Received June 24, 2021

    Report

    Report Number
    3010079947-2021-00179
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    May 29, 2021
    Report Date
    May 29, 2021
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PHYSICIAN CONFIRMED THAT NO PUMP ISSUES WERE NOTED AT THE PATIENT'S MOST RECENT REFILL APPOINTMENT, AND THAT THE PATIENT'S REPORTED PAIN WAS DUE TO FIBROMYALGIA. PHYSICIAN STATED THAT THEY HAVE NO FURTHER INFORMATION ON THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SENT. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    PHYSICIAN'S OFFICE INFORMED POST MARKET SURVEILLANCE THAT THE PATIENT WAS LAST REFILLED WITH NO DISCREPANCIES OR ISSUES WITH THE PUMP NOTED. THE PATIENT'S REPORTED PAIN WAS DETERMINED TO BE DUE TO FIBROMYALGIA.

    Additional Manufacturer Narrative · 1

    FCE REPORTED THAT THE PATIENT HAS PREVIOUSLY COMPLAINED THAT 'THE PUMP DOES NOT SEEM TO BE WORKING', IN ADDITION TO UNRELIEVED PAIN. FCE HAS INFORMED THE PATIENT TO FOLLOW-UP WITH PHYSICIAN. PATIENT IS REPORTEDLY GETTING AN MRI OF THEIR BRAIN. PENDING FURTHER FOLLOW-UP WITH PATIENT'S PHYSICIAN. A REVIEW OF THE DEVICE HISTORY RECORD, WHICH INCLUDES VERIFICATION OF ALL STEPS IN THE MANUFACTURING OF THE PUMP, VERIFICATION OF ALL FINAL TESTING PERFORMED BY/ON THE PUMP, VERIFICATION OF STERILIZATION, AND PACKAGING FOR SUBJECT PUMP WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, ISSUES OR CAPAS ASSOCIATED WITH PUMP FUNCTION. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED FIELD CLINICAL ENGINEER (FCE) TO REPORT THAT THEY BELIEVED THEIR PUMP TO BE LEAKING FLUID. THE PATIENT REPORTED THAT THEY WERE IN THE ER WITH A POCKET OF FLUID UNDER THEIR SKIN ON TOP OF THEIR SPINE, STATED TO BE EDEMA. PATIENT HAS REPORTEDLY EXPERIENCED AN INCREASE PAIN WITH NO WITHDRAWAL SYMPTOMS. THEIR DOCTOR HAD REPORTEDLY GIVEN THEM PRESCRIPTIONS TO DEAL WITH THE INCREASED PAIN. PATIENT STATED THAT A CT SCAN WAS PERFORMED WHICH SHOWED ALL (PUMP/CATHETER) WAS CONNECTED AND IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956839 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC. 13827 27196 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O