BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT VR RF

    MDR report key: 4061842 · Received September 4, 2014

    Report

    Report Number
    2938836-2014-15526
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    July 14, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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 PRESENTED IN THE EMERGENCY ROOM FOLLOWING A PRESYNCOPAL EVENT. THE PATIENT WAS FOUND TO BE IN A VT THAT WAS NOT BEING TREATED BY THE DEVICE DUE TO THE PROGRAMMING. THE PATIENT WAS EXTERNALLY CARDIOVERTED AND THE DEVICE WAS REPROGRAMMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540462 CURRENT VR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention