BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE-FIXATION LEAD

    MDR report key: 741278 · Received July 11, 2006

    Report

    Report Number
    2938836-2006-00485
    Event Type
    Injury
    Date Received
    July 11, 2006
    Date of Event
    June 12, 2006
    Report Date
    June 12, 2006
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE VENTRICULAR LEAD. THE NOISE LED TO MULTIPLE INAPPROPRIATE AND ABORTED THERAPIES. THE PT WAS ASYMPTOMATIC. ST. JUDE MEDICAL TECHNICAL SERVICES REVIEWED THE FAXED ELECTROGRAMS AND DISCUSSED THAT THE NOISE WAS INDICATIVE OF AN INSULATION BREAK OR A LEAD FRACTURE. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE-FIXATION LEAD DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL, INC., CRMD 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention