BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1955097 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00064
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 5, 2010
    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN ABORTED HV THERAPY DUE TO POSSIBLE OUTPUT CIRCUIT DAMAGE. IT WAS NOTED THAT TACHY EPISODE WAS UNSUCCESSFUL AND AFTER THE FIRST SHOCK, THE DEVICE DID NOT LOAD APPROPRIATELY FOR THE SECOND SHOCK. BOTH THE LEAD AND ICD WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)