BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPREME

    MDR report key: 15310308 · Received August 29, 2022

    Report

    Report Number
    15310308
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    August 17, 2022
    Report Date
    August 22, 2022
    Manufacturer
    ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NON-FUNCTIONING ELECTRODE ON JSN CATHETER. REPLACED CABLE AND STILL DID NOT WORK. REMOVED FROM BODY AND REPLACED WITH NEW CATHETER. NEW CATHETER WORKED. NO HARM DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318852 SUPREME CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL CARDIOVASCULAR DIVISION 401890 8350391

    Patients

    Seq Age Sex Outcome Treatment
    1 27740 DA Female