BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITY ADX XL

    MDR report key: 1223365 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03184
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    June 20, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT SENSING VALUES RANGED FROM 1.5 MV TO 10 MV AND VARYING THRESHOLD VALUES WERE NOTED. A FOLLOW-UP THE NEXT DAY FOUND THE SAME VARIABILITY. THE PHYSICIAN REOPENED THE POCKET AND CHECKED THE LEAD WITH A PACING SYSTEM ANALYZER (PSA). VALUES WITH THE PSA WERE STABLE. THE DEVICE WAS RECONNECTED AND CONTINUED TO EXHIBIT THE SAME VARIABLE VALUES, SO THE PHYSICIAN ELECTED TO REPLACE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERITY ADX XL IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5256 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention