BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2420589 · Received January 18, 2012

    Report

    Report Number
    2017865-2012-00715
    Event Type
    Death
    Date Received
    January 18, 2012
    Date of Event
    December 7, 2011
    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
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DURING VF THAT RETURNED THE PATIENT TO SINUS RHYTHM. PREVIOUS PICTURES OF LEAD, SHOWED INSULATION ABRASION. WE WERE LATER INFORMED PATIENT EXPIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BEING TRANSPORTED TO THE ER VIA AMBULANCE FOR REASONS THE PHYSICIAN BELIEVE ARE NOT DEVICE RELATED. DURING TRANSPORT, THE PATIENT HAD AN EPISODE OF VF. THERAPY WAS NOT DELIVERED A ND PATIENT WAS EXTERNALLY DEFIBRILLATED. AN ALERT WAS RECEIVED FOR POSSIBLE OUTPUT CIRCUIT DAMAGE AND LOW IMPEDANCE. PATIENT SUSTAINED SIGNIFICANT BRAIN INJURY BUT THE PHYSICIAN DOES NOT BELIEVE DEVICE RELATED SINCE PATIENT RECEIVED AN EXTERNAL SHOCK

    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 61 YR Death (B)(4)