BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 1830615 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03200
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 1, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS REVEALED ABRASIONS ON OUTER INSULATION AND INSULATION ON ONE OF THE SENSING CABLES UNDER THE PROXIMAL END OF THE RV COIL. THE METAL WIRES OF THE SENSING CABLE WERE EXPOSED AT THE SAME AREA; THIS WOULD CAUSE THE REPORTED NOISE WHEN IN CONTACT WITH THE RV COIL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO NOISE ON THE LEAD. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention