BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 3210792 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03318
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 13, 2013
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP, MULTIPLE VF EPISODES WERE SEEN DUE TO NOISE. THE DEVICE HAD STARTED CHARGING BUT ALL HAD BEEN ABORTED WITH RETURN TO SINUS AFTER A FEW SECONDS. THENOISE WAS REPRODUCED BY POCKET MANIPULATION. HIGH VOLTAGE THERAPY WAS TURNED OFF. THE LEAD WILL BE EXPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310007 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7020/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR