BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY DR+

    MDR report key: 246932 · Received March 10, 1999

    Report

    Report Number
    2017865-1999-00401
    Event Type
    Injury
    Date Received
    March 10, 1999
    Date of Event
    February 5, 1999
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED NOTES THAT WHEN THE PATIENT WAS SEEN FOR A ROUTINE FOLLOW-UP, THE PACEMAKER MODE WAS VOO AT A RATE OF 51.9 PPM DURING MAGNET APPLICATION. DEMAND MODE SHOWED THAT THE PATIENT'S INTRINSIC RATE WAS IN THE 80'S. INTERROGATION REVEALED DASHES (---) FOR SENSOR, RATE, HYS- TERESIS AND SLEEP PARAMETERS. HIGH CURRENT DRAIN WAS ALSO NOTED. THE MESSAGE "REPROGRAM" WAS DISPLAYED AND VALUES WERE PROGRAMMABLE, BUT THE DASHES RETURNED UPON INTERROGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY DR+ Implant IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2360L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention