BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION LEAD

    MDR report key: 1073110 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02352
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 2, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EXPERIENCE WAS CONFIRMED. THE INNER INSULATION AND SENSING CABLE INSULATION WERE CUT/DAMAGED","AT 21.8 CM FROM THE CONNECTOR PIN. THE DAMAGED INSULATIONS CAUSED INTERMITTENT CONTACT BETWEEN THE INNER COIL AND THE SENSING CABLE AND RESULTED IN THE REPORTED OVERSENSING. THERE ARE NO INDICATIONS OF DEFICIENCY IN MATERIAL OR WORKMANSHIP.

    Description of Event or Problem · 1

    PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO OVERSENSING. THE OVERSENSING WAS REPRODUCIBLE. AS SUCH, THE LEAD WAS EXPLANTED AND REPLACED WITH NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention