BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3890789 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04357
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    June 28, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 NORMAL ERI GENERATOR CHANGE OUT, LOSS OF VENTRICULAR CAPTURE WAS NOTED. LEAD FRACTURE WAS ALSO NOTED AND WAS CONSISTENT WITH CLAVICULAR CRUSH. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28024 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD, NVY NVY ST. JUDE MEDICAL INC., CRMD 7000/65

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR