BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT PLUS DR, DF4 CONNECTOR

    MDR report key: 3220126 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04445
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 22, 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
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN THE EMERGENCY ROOM WITH A DEVICE THAT WAS POST-SENSED T-WAVE OVERSENSING. THE OVERSENSING WAS NOTED ON A STORED EGM. THE PATIENT RECEIVED INAPPROPRIATE ATP. PROGRAMMING CHANGES WERE RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320578 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 79 YR