BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 11517681 · Received March 18, 2021

    Report

    Report Number
    3010079947-2021-00081
    Event Type
    Injury
    Date Received
    March 18, 2021
    Date of Event
    January 26, 2021
    Report Date
    February 18, 2021
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL MDR WILL BE SENT IF/WHEN ADDITIONAL INFORMATION IS OBTAINED. DEVICE WAS NOT RETURNED. PER THE INSTRUCTIONS FOR USE OF THE DEVICE, INFECTION IS A KNOWN POSSIBLE RISK OF USE OF THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    DURING FOLLOW-UP FOR THE COMPLAINT ASSOCIATED WITH MFR 3010079947-2020-000259 , IT WAS CONFIRMED THAT THE PATIENT HAD AN INFECTION AND WAS HOSPITALIZED. THE PATIENT'S PUMP WAS EXPLANTED AT A LATER DATE. ADDITIONAL ATTEMPTS OF FOLLOW-UP WERE UNSUCCESSFUL AS THE NEUROSURGERY OFFICE WOULD NOT RELEASE PATIENT-RELATED INFORMATION. MFR 3010079947-2020-000259 WAS OPENED TO ADDRESS CATHETER ASPIRATION ISSUES FOR THE SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416339 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC. 13827

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R