BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION LEAD

    MDR report key: 3895240 · Received June 25, 2014

    Report

    Report Number
    2938836-2014-06416
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    January 25, 2013
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 NOISE ON THE VENTRICULAR AND ATRIAL CHANNELS TRIGGERS INAPPROPRIATE DIAGNOSIS. CAPACITOR CHARGED BUT DID NOT DELIVERY THERAPIES. LOW PACING IMPEDANCE WAS OBSERVED. CAN TO LEAD ABRASION WAS SUSPECTED. THE LEAD REMAINS IMPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE LEAD WAS REPLACED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371737 RIATA ACTIVE FIXATION LEAD DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL INC., CRMD 1580-65

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention