BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS

    MDR report key: 20169388 · Received September 9, 2024

    Report

    Report Number
    3003832357-2024-00668
    Event Type
    Death
    Date Received
    September 9, 2024
    Date of Event
    August 30, 2024
    Report Date
    November 14, 2024
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO THE COMPONENT CODE GRID, EVALUATION RESULTS GRID AND THE CONCLUSION CODE GRID.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THE DEVICE FAILURE TO PACE WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601257 TEMPUS LS LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death