BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC VR

    MDR report key: 4554016 · Received February 27, 2015

    Report

    Report Number
    2938836-2015-01775
    Event Type
    Injury
    Date Received
    February 27, 2015
    Date of Event
    January 9, 2015
    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
    IT
    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 DURING THE REPLACEMENT PROCEDURE, A VF EPISODE CAUSED BY T-WAVE OVERSENSING WAS OBSERVED. AN OLDER EPISODE WITH UNDERSENSING WAS OBSERVED. THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138287 EPIC VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-197 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention