BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC DR

    MDR report key: 3920905 · Received July 8, 2014

    Report

    Report Number
    2938836-2014-13326
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    September 9, 2004
    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
    TX, 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 HAD TO BE EXTERNALLY DEFIBRILLATED WHEN A VF EPISODE WAS UNDERSENSED. THE DEVICE WAS REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398299 EPIC DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-235 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention