BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC PLUS VR

    MDR report key: 3650638 · Received February 27, 2014

    Report

    Report Number
    2938836-2014-07238
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Date of Event
    March 7, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENT OF THE INABILITY TO REMOVE THE LEAD FROM THE HEADER WAS NOT CONFIRMED IN THE LABORATORY. UPON RECEIPT, THE HEADER WAS NOT ATTACHED TO THE DEVICE AND THE V IS-1 BI CONNECTOR BLOCKS DID NOT CONTAIN THEIR SEPTA OR SET SCREWS. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND. THE CAUSE OF THE FIELD EVENT COULD NOT BE DETERMINED BECAUSE THE V IS-1 BI SEPTA AND SET SCREWS WERE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REMOVED DUE TO ELECTIVE REPLACEMENT INDICATOR. UPON EXPLANT, IT BECAME DIFFICULT TO REMOVE THE LEAD FROM THE HEADER OF THE DEVICE. BONE CUTTERS WERE USED ON THE HEADER. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120365 EPIC PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-196 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR