BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN 3000

    MDR report key: 17414372 · Received July 28, 2023

    Report

    Report Number
    3015537318-2023-00028
    Event Type
    Injury
    Date Received
    July 28, 2023
    Report Date
    July 27, 2023
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    LKK
    UDI-DI
    01088670403607
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERA ONCOLOGY ACQUIRED PMA P890055 FROM CODMAN & SHURTLEFF/CERENOVOUS IN 2020. INTERA ONCOLOGY DOES NOT CURRENTLY MANUFACTURE THE 3000 LOW FLOW INFUSION PUMP. INTERA ONCOLOGY DOES NOT CURRENTLY MARKET DEVICES FOR MORPHINE OR BACLOFEN INFUSION. BLANK INFORMATION IN THE MDR FORM REPRESENTS UNKNOWN INFORMATION. IF FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    PATIENT RESPONDED TO A ROUTINE DEVICE TRACKING MAILING . THE PATIENT WROTE ON THE DEVICE TRACKING CARD "NO DOCTOR WILL FILL MY PUMP NOR WILL THEY TAKE IT OUT. I HAVE BURNING AROUND THE PUMP BUT I GUESS THAT OK." IT WAS DETERMINED TO BE A CODMAN 3000 LOW FLOW PUMP, IMPLANT DATE (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966731 CODMAN 3000 IMPLANTABLE DRUG INFUSION PUMP LKK CODMAN & SHURTLEFF 3000-L 01088670403607

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention