BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION LEAD

    MDR report key: 4091846 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05195
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 5, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    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. 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. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF HELIX NOT EXTENDING PRIOR TO IMPLANT COULD NOT BE CONFIRMED IN THE LABORATORY. HOWEVER, THERE WAS A WHITE FOREIGN MATERIAL FOUND ON THE HELIX, THIS COULD HAVE BEEN THE CAUSE OF HELIX EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO IMPLANT THE HELIX WAS TESTED AND IT WAS NOTED THAT IT WOULD NOT EXTEND. THIS LEAD WAS NOT IMPLANTED. THE PATIENTS CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34122 RIATA ST OPTIM ACTIVE FIXATION LEAD DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL INC., CRMD 7022/65

    Patients

    Seq Age Sex Outcome Treatment
    1