BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1073055 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02300
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 3, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    AS RECEIVED, A PARTIAL LEAD WAS RETURNED, DAMAGED. SUTURE SLEEVE MARKS WERE NOTED AT 45CM AND 45.9 CM FROM THE DISTAL TIP. SEM PHOTOGRAPHY CONFIRMED THAT BOTH IS-1 PROXIMAL CABLES AND FOUR WIRES OF THE IS-1 DISTAL COIL WERE FRACTURED, CONSISTENT WITH THE SUTURE SLEEVE BEING TIGHTENED DOWN TOO TIGHT ON THE LEAD. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO THE ER AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE THERAPY. REVIEW OF THE EPISODES REVEALED NOISE ON THE LEAD. A CLAVICULAR CRUSH WAS NOTED AT EXPLANT.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURE;PBU CABLE.SPECIFIC COMPONENT(S) INVOLVED: COMPONENT: PBU CABLE.CAUSATIVE OR CONTRIBUTING FACTOR: PATIENT NONCOMPLIANCE IN DEVICE MAINTENANCE AND PROTECTION.INTERVENTION(S): REMINDED PT ABOUT CARE OF EQUIPMENT.IMPLANT DEVICE TYPE: LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention