BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICTORY XL DR

    MDR report key: 1896152 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05331
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    July 1, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED A FOUR SECOND PAUSE IN PACING ON THE HOLTER MONITOR. THE PHYSICIAN DECREASED SENSITIVITY AND THE PATIENT WAS SENT TO THE HOSPITAL FOR A DOUBLE CHECK. THE PATIENT PRESENTED SYNCOPAL WITH VENTRICULAR INHIBITION AND UNDERSENSING. THE PULSE GENERATOR WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICTORY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5816 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention