BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST PASSIVE FIXATION LEAD

    MDR report key: 3890374 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03620
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    January 8, 2013
    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 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 OT THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP, THE PHYSICIAN NOTICED A CHANGING IN THE RC LEAD PARAMETERS, INCLUDING INCREASED THRESHOLD AND HIGH VOLTAGE LEAD IMPEDANCE AND PACING LEAD IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30403 RIATA ST PASSIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL INC., CRMD 7040-65

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention