BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 4221083 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17437
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 19, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PATIENT PRESENTED IN HOSPITAL FOR UNRELATED CONDITION, DEVICE INTERROGATION REVEALED THAT NON-CAPTURE EVENTS COINCIDED WITH NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING EPISODES. THE PATIENT WAS PREVIOUSLY DIAGNOSED WITH ORTHOSTATIC HYPOTENSION AND HAD FALLEN. INCREASED CAPTURE THRESHOLD WAS NOTED FOLLOWING THE DIAGNOSIS. IT WAS SUSPECTED THAT THE LEADS MAY HAVE BEEN IMPACTED BY THE FALL. THE PATIENT WAS PRESYNCOPAL DURING THE LOSS OF CAPTURE EVENTS. THE DEVICE WAS RE-PROGRAMMED AND THE PATIENT WILL CONTINUE TO BE MONITORED. NO FURTHER EPISODES HAVE OCCURRED SINCE THE REPROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703137 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7020/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention 1458Q/86 BPP028586