BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 2973391 · Received February 21, 2013

    Report

    Report Number
    2938836-2013-00188
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 28, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE PROXIMAL PORTION MEASURING 17.0CM WAS RETURNED FOR ANALYSIS. THE PORTION OF THE LEAD THAT WAS RETURNED WAS FOUND TO BE NORMAL. NO FRACTURES WERE OBSERVED VIA X-RAY ANALYSIS. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPLANTED DUE TO A FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75544 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7002/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1