BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE-FIXATION LEAD

    MDR report key: 730776 · Received June 30, 2006

    Report

    Report Number
    2938836-2006-00514
    Event Type
    Injury
    Date Received
    June 30, 2006
    Date of Event
    June 5, 2006
    Report Date
    June 5, 2006
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INT 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 EXPLANTED DUE TO CHANGE IN THRESHOLDS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention THERAPY DATES: NA