BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1954986 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00091
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 22, 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 Location
    SC
    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 DURING A DFT TESTING THE DEVICE FAILED TO DELIVER A SHOCK. AN ALERT OF POSSIBLE OUTPUT CIRCUIT DAMAGE WAS OBSERVED. THE PATIENT WAS EXTERNALLY RESCUED. AN INSULATION BREAK WAS OBSERVED DURING THE EXPLANT PROCEDURE. THE LEAD WAS CAPPED.

    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 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention