BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 4153570 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16345
    Event Type
    Death
    Date Received
    October 8, 2014
    Date of Event
    September 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 AN ELECTIVE DEVICE UPGRADE, THE PHYSICIAN ELECTED TO EXPLANT THE RV LEAD IN ORDER TO GAIN ACCESS, SINCE THE PATIENT WAS COMPLETELY OCCLUDED. DURING THE PROCEDURE, THE SVC WAS TORN AND THE PATIENT EXPIRED. FURTHER INFORMATION RECEIVED NOTES THAT A LASER SHEATH WAS ADVANCED TO THE SVC JUNCTION. THE LEAD WAS SUCCESSFULLY EXTRACTED. AFTER LASER SHEATH REMOVAL, THE PATIENTS BLOOD PRESSURE DROPPED, POSSIBLE HEMOTHORAX WAS NOTED ON FLUOROSCOPY. THE PATIENT WAS PLACED ON BYPASS AND AN EMERGENT THORACOTOMY WAS PERFORMED. THE PROCEDURE WAS COMPLICATED BY SEVERE COAGULOPATHY. DESPITE ALL EFFORTS, THE PATIENT EXPIRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631893 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7000/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death