BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 4170075 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02913
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    April 12, 2012
    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
    TN, 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 ABOUT THE DEVICE NOT ABLE TO RESCUE DURING DFT AND DID NOT DETECT ARRHYTHMIA (SENSING) WAS NOT CONFIRMED. THE DEVICE WAS TESTED ON THE BENCH AND ON UTS. UTS DETECTED NO ANOMALY AND THE DEVICE MET ALL SPECIFICATIONS. THE CAUSE OF THE FAILURE OF DFT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT ABLE TO RESCUE DURING DFT AND IT DID NOT DETECT ARRHYTHMIA (SENSING). THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23675 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS LWS ST. JUDE MEDICAL INC., CRMD 2207-36

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 1580/60, RD10583