BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3220179 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04252
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 28, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. INTERROGATION, OVERSENSING CAUSED THE INAPPROPRIATE SHOCKS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM BECAUSE, HE WAS NOT FEELING GOOD. THE PATIENT WAS ADMITTED TO THE ICU FOR ACIDOSIS, WHILE IN THE ICU INAPPROPRIATE SHOCKS WERE NOTED. A MAGNET WAS PLACED ON THE DEVICE TO DISABLE THERAPY. THE NEXT MORNING, THE PATIENT EXPERIENCED REAL VF, THE MAGNET WAS REMOVED AND THE DEVICE SENSED, DIAGNOSED AND TREATED THE VF. ONE HOUR LATER, THE PATIENT CONDITION DETERIORATED AND CPR WAS STARTED. UPON

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320874 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R