BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3890610 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04417
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 25, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR LEAD NOISE. THE LEAD WAS SCHEDULED FOR REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27863 RIATA ST ACTIVE FIXATION DIFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC. CRMD 7002/60

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR