BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE-FIXATION LEAD

    MDR report key: 730989 · Received June 29, 2006

    Report

    Report Number
    2938836-2006-00501
    Event Type
    Injury
    Date Received
    June 29, 2006
    Date of Event
    May 17, 2006
    Report Date
    May 17, 2006
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IN ITS ENTIRETY WAS COMPLETED SOLELY BY ST. JUDE MEDICAL, INC., CRMD. H.3. EVALUATION SUMMARY: ANALYSIS FOUND THE LEAD TO EXHIBIT NORMAL ELECTRICAL CHARACTERISTICS. MECHANICAL AND VISUAL ANALYSIS FOUND DRIED BODY FLUID/TISSUE ON THE DISTAL COIL, PREVENTING EXTENSION OF THE HELIX. THE ENSURING RESISTANCE MAY HAVE RESULTED IN AN OVER-TORQUE CONDITION. ONCE THE HELIX WAS CLEANED, IT WAS TESTED AND FOUND TO FUNCTION NORMALLY. NO OTHER ABNORMALITIES WERE NOTED ASIDE FROM THE PHYSICAL DAMAGE POSSIBLY SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP THE MEASUREMENTS SHOWED A DROP IN R-WAVES AND AN INCREASE FOR PACING THRESHOLDS. X-RAY EXAMINATION CONFIRMED A VENTRICULAR PERFORATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention THERAPY DATES: NA