BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAGON III

    MDR report key: 268708 · Received March 14, 2000

    Report

    Report Number
    2017865-2000-00357
    Event Type
    Malfunction
    Date Received
    March 14, 2000
    Date of Event
    December 28, 1999
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE FIELD NOTES LOSS OF ATRIAL SENSING. THE PATIENT WAS IN SINUS RHYTHM AT 68 BPM. THE DEVICE WAS PROGRAMMED TO 50 PPM IN DDD MODE WITH +PVARP ON PVC TURNED ON. DUE TO THE LOSS OF SENSING, THE DEVICE ACTED AS IF THE CONDUCTED R WAVE WAS A PVC. THE +PVARP ON PVC FEATURE WAS CAUSING THE DEVICE TO LEAD WITH AN ATRIAL PACE. THIS WAS RESOLVED BY TURNING OFF THE +PVARP ON PVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARAGON III IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2315M/S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR