BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT DR RF

    MDR report key: 3884745 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12133
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    April 18, 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
    WI, US
    Reporter Occupation
    NURSE

    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 RECEIVED INAPPROPRIATE THERAPY AND PRESENTED IN THE ER. MERLIN TRANSMISSION SHOWED PATIENT IN AFIB WITH RAPID VENTRICULAR RESPONSE. PROGRAMMING CHANGES WERE MADE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361386 CURRENT DR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention