BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITY ADX XL VDR

    MDR report key: 2983763 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01605
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    December 12, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL EXPERIENCING COMPLETE AV BLOCK AND ESCAPE RHYTHM OF 20 BEATS PER MINUTE. ON (B)(6) DURING THE REPLACEMENT PROCEDURE, THE DEVICE EXHIBITED LOSS OF OUTPUT AND THE PT HAD TO BE RESUSCITATED. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87926 VERITY ADX XL VDR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5456I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention