BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS DR, DF-4 CONNECTOR

    MDR report key: 4153434 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16373
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 20, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    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 PATIENT WAS IN CHRONIC ATRIAL FIBRILLATION AND SVT EPISODES WERE DIAGNOSED AS VENTRICULAR TACHYCARDIA. THE PATIENT RECEIVED ATP THERAPY AND TWO HIGH VOLTAGE SHOCKS. IT WAS DETERMINED THAT THE MORPHOLOGY DISCRIMINATOR WAS NOT WORKING WELL FOR THIS PATIENT, BUT THE MAJORITY OF EPISODES WERE CORRECTLY DIAGNOSED. IT WAS RECOMMENDED TO OPTIMIZE THE TREATMENT OF THE ATRIAL FIBRILLATION WITH MEDICATION, AND THEN PERFORM PROGRAMMING CHANGES IF NECESSARY. THE DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630361 CURRENT PLUS DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention