BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE-FIXATION LEAD

    MDR report key: 771474 · Received October 17, 2006

    Report

    Report Number
    2938836-2006-00803
    Event Type
    Injury
    Date Received
    October 17, 2006
    Date of Event
    September 18, 2006
    Report Date
    September 18, 2006
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NOISE WAS OBSERVED ON THE ELECTROGRAMS INDICATIVE OF A CONDUCTOR FRACTURE. THE NOISE OCCURRED WHILE THE PT WAS SHAKING POM-POMS AT A GAME. THE SALES REP HAD THE PT MIMIC THIS MOTION AND WAS ABLE TO REPRODUCT THE NOISE. AS A RESULT, LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE-FIXATION LEAD DEFIBRILLATOR LEAD DTB ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention THERAPY DATES