BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2242813 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06083
    Event Type
    Death
    Date Received
    September 10, 2011
    Date of Event
    June 21, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE LEAD WAS RECEIVED IN TWO PIECES. AN EXTERNAL ABRASION CAUSED BY FRICTION TO ICD WAS FOUND AT 16.0-16.5CM FROM THE CONNECTOR PIN. ANOTHER EXTERNAL ABRASION WAS FOUND AT 10.0-10.5CM FROM THE DISTAL TIP; THIS ABRASION WAS CONSISTENT WITH FRICTION TO ANOTHER IMPLANTED DEVICE. THE ETFE COATING WAS NORMAL AT THESE TWO LOCATIONS.

    Description of Event or Problem · 1

    WE WERE LATER INFORMED THAT THE PATIENT RECEIVED SEVERAL SHOCKS FROM HIS DEVICE AND WAS TRANSPORTED TO THE HOSPITAL. DURING TRANSPORT, THE PATIENT WAS IN SEVERE PAIN AND THEN, HE BECAME UNRESPONSIVE, HAD SEIZURE-LIKE ACTIVITY, AND BECAME PULSELESS AND APNEIC. EKG SHOWED VF WHICH REMAINED DURING RESUSCITATIVE EFFORTS. THE INFORMATION RECEIVED NOTED THAT THE PATIENT WAS PRONOUNCED DEAD AT THE ER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT THOUGHT HE MAY HAVE PINCHED THE AREA WHERE THE LEAD IS IMPLANTED. PACING LEAD IMPEDANCE MEASUREMENTS HAD BEEN STEADILY INCREASING SINCE THEN. THE CAPTURE THRESHOLD WAS ALSO HIGH. ISO METRICS AND POSITIONAL TESTING DELIVERED THERAPY WITHOUT PROBLEM.

    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 52 YR Death