BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3220296 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04220
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 17, 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 Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS RECORD IS A DUPLICATE ENTRY OF MDR NUMBER 2938836-2013-00176. THIS RECORD SHOULD BE DELETED/RETRACTED AND THE INFORMATION CAN BE FOUND IN THE SUPPLEMENTAL REPORT FOR MDR NUMBER 2938836-2013-00176.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT RECEIVED AN ALERT MERLIN.NET TRANSMISSION SHOWING NON-SUSTAINED LEAD NOISE EPISODES AND SECURESENSE INHIBITION OF THERAPY FROM NOISE. REVIEW OF THE EGM SHOWED NOISE ON THE RV BIPOLAR EGM CHANNEL. THE PATIENT RECEIVED INAPPROPRIATE ATP THERAPY DUE TO NOISE ON ONE EPISODE. IT WAS ALSO NOTED THAT THE RV LEAD WAS PREVIOUSLY CAPPED AND WAS NOW RUBBING AGAINST ANOTHER LEAD, WHICH WAS GENERATING THE NOISE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319602 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention