BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT ACCEL DR, DF-4 CONNECTOR

    MDR report key: 3881142 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02228
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 20, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    DXY
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP WITH A DEVICE THAT WAS POST PACED T WAVE OVERSENSING ON THE VENTRICULAR LEAD. THE PATIENT DID NOT RECEIVED THERAPY AND THE OVERSENSING WAS NOTED ON A REAL TIME ELECTROGRAM. REPROGRAMMING CHANGES WERE RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30203 CURRENT ACCEL DR, DF-4 CONNECTOR LWS DXY ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD2215-36Q

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR