BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1878924 · Received October 21, 2010

    Report

    Report Number
    2017865-2010-04228
    Event Type
    Death
    Date Received
    October 21, 2010
    Date of Event
    September 12, 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
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVENTUALLY DELIVERED THERAPY. THE SHOCK WAS DELAYED DUE TO INTERMITTENT UNDERSENSING OF FINE VF. IT IS NOT KNOWN HOW THE DEVICE WAS SET UP TO SENSE. FROM THE LIMITED DATA AVAILABLE, IT DOES NOT APPEAR THAT THE DEVICE ACTIVELY CAUSED THE PATIENT'S DEATH. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. ANALYSIS OF THE LEAD FOUND DAMAGE THAT WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY, CAUSE UNKNOWN. REVIEW OF THE PRINTOUTS SHOWED VT/VF EPISODES. PATIENT'S RHYTHM APPEARED TO DECLINE FROM FAST SINUS TO A FINE VF. FIRST EPISODE SHOWED INTERMITTENT UNDERSENSING OF FINE VF CAUSING THE DEVICE TO DETECT AND CHARGE FOR VF BUT THE UNDERSENSING CAUSED DEVICE TO RETURN TO SINUS WITHOUT THERAPY DELIVERED. SECOND EPISODE SHOWED ANOTHER UNDERSENSING. HOWEVER, THE DEVICE DETECTED, CHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7001/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death 2207-36, (B)(4), 1888TC/52, (B)(4)