BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3801394 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10979
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 11, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HV THERAPY DUE TO NOISE ON THE RV LEAD. IT WAS ALSO NOTED THAT THE PATIENT HAD SEVERAL BURST OF HIGH FREQUENCY NOISE SIMULTANEOUSLY ON THE ATRIAL AND V SENSE CHANNELS. LEAD WAS CAPPED AND REPLACED. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278954 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention (B)(4)