BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS LS-MANUALS

    MDR report key: 17779871 · Received September 20, 2023

    Report

    Report Number
    3003832357-2023-00607
    Event Type
    Injury
    Date Received
    September 20, 2023
    Date of Event
    August 21, 2023
    Report Date
    July 1, 2024
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT TEMPUS LS PACING WAS ATTEMPTED, OUTPUT WOULD NOT INCREASE ABOVE 35MA, AND CAPTURE WAS NOT ACHIEVED. THEY RESTARTED THE LS AND ATTEMPTED TO PACE. THIS TIME, THE PACING OUTPUT WOULD NOT INCREASE ABOVE 25MA AND CAPTURE WAS NOT ACHIEVED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801877 TEMPUS LS-MANUALS LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Other