BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 3890886 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03698
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    February 27, 2013
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 DURING FOLLOWUP, THE PHYSICIAN NOTICED VARIATION IN THE PACING AND HIGH VOLTAGE LEAD IMPEDANCES. THE PHYSICIAN DECIDED TO CONTINUE TO MONITOR THE PATIENT. THE LEAD REMAINS IN SERVICE AND THE PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28048 RIATA PASSIVE FIXATION DEFIBRILLATION LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 1570/65

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR