BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS DR, DF4 CONNECTOR

    MDR report key: 3101127 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01924
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    February 6, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DEVICE WAS OVER-SENSING T-WAVES ON THE VENTRICULAR LEAD. THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS ASYMPTOMATIC AND NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP WHEN IT WAS REPORTED THE DEVICE WAS POST-SENSED T-WAVE OVERSENSING ON THE VENTRICULAR CHANNEL. THE PATIENT RECEIVED INAPPROPRIATE HV THERAPY DUE TO THE OVERSENSING. THE OVERSENSING WAS NOTED ON A STORED EGM AND THE REAL-TIME EGM. REVIEW OF THE EPISODES REVEALED THE PREVIOUS VF EPISODE COULD NOT BE RESOLVED WITH PROGRAMMING ADJUSTMENTS. REVIEW OF THE OTHER EPISODES SHOWED R WAVES VARYING FOLLOWED BY T WAVE AMPLITUDES VARYING. PROGRAMMING CHANGES WERE RECOMMENDED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT WHEN THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP, IT WAS NOTED THAT THE PATIENT RECEIVED INAPPROPRIATE HV THERAPY DUE TO POST-SENSED T-WAVE OVERSENSING ON THE VENTRICULAR CHANNEL. FURTHER REPROGRAMMING CHANGES WERE MADE. PATIENT CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202975 CURRENT PLUS DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention