BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 3791169 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10469
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 31, 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
    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 BASELINE NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR LEAD. THE NOISE RESULTED IN INHIBITION OF VENTRICULAR PACING. A DROP IN SENSING WAS ALSO OBSERVED. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268908 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7021/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention