BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4172368 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-01806
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 23, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. 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. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE FOLLOW UP, MULTIPLE ABORTED THERAPIES WAS NOTED DUE TO LEAD NOISE. PATIENT HAS SEPARATE HV LEAD AND PACE/SENSE LEAD DUE TO PREVIOUS UNDERSENSING ISSUES. EGMS SHOWED INTERFERENCE WHICH WAS THOUGHT TO BE CAUSED BY LEADS KNOCKING TOGETHER. DURING DEVICE CHANGE OUT DUE TO NORMAL ERI, PACE/SENSE LED WAS REMOVED WITH NOTED BLOOD INGRESS INTO INSULATION AND SMALL INSULATION FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28945 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL INC., CRMD 1582/65

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)