BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO

    MDR report key: 414323 · Received July 9, 2002

    Report

    Report Number
    2017865-2002-00562
    Event Type
    Injury
    Date Received
    July 9, 2002
    Date of Event
    May 29, 2002
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE FIELD NOTES THAT THE PATIENT PRESENTED ASYMPTOMATIC FOR A ROUTINE FOLLOW-UP. THE DEVICE COULD NOT BE INTERROGATED AND THERE WERE NO APPARENT PACER SPIKES DISPLAYED. AT A PREVIOUS FOLLOW-UP IN JANUARY 2002, >27 MONTHS REMAINING UNTIL RRT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPO IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2102 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention