BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2902526 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00334
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    November 6, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED A PARTIAL LEAD WAS RETURNED IN TWO PORTIONS, MEASURING 12.1CM OF THE IS-1 AND SVC PINS AND 6.4CM OF THE RV PIN. THE PORTIONS OF THE LEAD THAT WERE RETURNED WERE OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER AFTER RECEIVING SHOCKS. THE PATIENT'S PRESENTING RHYTHM WAS VT AND THE PATIENT WAS RESCUED EXTERNALLY. LOW SHOCK IMPEDANCE WAS OBSERVED DURING DEVICE TESTING. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10007 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR (B)(4), (B)(4)