BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN 3000

    MDR report key: 17367335 · Received July 20, 2023

    Report

    Report Number
    3015537318-2023-00024
    Event Type
    Injury
    Date Received
    July 20, 2023
    Report Date
    July 20, 2023
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    LKK
    UDI-DI
    10886704043607
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A COMPLAINT RECORD AS TRANSFERRED FROM PMA HOLDER MATCHING THE DEVICE SERIAL NUMBER WAS LOCATED; HOWEVER THE RECORD DOES NOT IDENTIFY IF THE COMPLAINT WAS PREVIOUSLY MDR REPORTED. 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 CALLED THE CLINICAL CALL LINE IN RESPONSE TO JUNE 2023 MAILING. THE MESSAGE FROM THE CCL WAS "HE IS THE PATIENT. VERY ANGRY HE RECEIVED THIS NOTICE SINCE YOU SHOULD KNOW WHERE THE PUMP IS ALREADY YOURSELF AND ANGRY THAT THE 'PUMP ALMOST KILLED HIM.'"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715886 CODMAN 3000 IMPLANTABLE DRUG DELIVERY PUMP LKK CODMAN & SHURTLEFF 3000-L 10886704043607

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention