BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION LEAD

    MDR report key: 3890302 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03690
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    July 17, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO WAS PROVIDED BY MFR, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SAW SEVERAL EPISODES IN THE VF ZONE ON DEVICE. THE EPISODES WERE DUE TO NOISE ON THE CHANNEL OF VENTRICULAR LEAD. 2 INAPPROPRIATE THERAPIES DUE TO NOISE ALSO OCCURRED. THE DEVICE AS REPROGRAMMED AND THE LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30420 RIATA PASSIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL INC., CRMD 1570/65

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention