BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC+ VR

    MDR report key: 4160762 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-01927
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    October 20, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. THE REPORTED COMPLAINT OF EXTENDED CHARGED TIME WAS CONFIRMED IN THE LABORATORY. THE CAUSE OF THE EXTENDED CHARGE TIME WAS CONFIRMED IN THE LABORATORY. THE CAUSE OF THE EXTENDED CHARGE TIME WAS FOUND OUT TO BE DUE TO THE BATTERY PERFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO EXTENDED CHARGE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26658 EPIC+ VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS LWS ST. JUDE MEDICAL INC., CRMD V-196

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention