BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION LEAD

    MDR report key: 731226 · Received June 27, 2006

    Report

    Report Number
    2938836-2006-00492
    Event Type
    Injury
    Date Received
    June 27, 2006
    Date of Event
    May 16, 2006
    Report Date
    May 16, 2006
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTE IN ITS ENTIRETY WAS COMPLETED SOLELY BY ST. JUDE MEDICAL, INC., CRMD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO ST. JUDE MEDICAL THAT THE LEAD WAS REPLACED AFTER IT HAD BEEN REPOSITIONED DUE TO A SENSING ANOMALY AND HIGH THRESHOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION LEAD DEFIBRILLATON LEAD LWS ST. JUDE MEDICAL, INC., CRMD 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention V-243, THERAPY DATES