BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1223126 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03745
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 14, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO NOISE SENSED ON THE ATRIAL AND VENTRICULAR CHANNELS AS SEEN ON EGMS. ALTHOUGH THE PATIENT STATED THAT THERE WAS AN ELECTRICAL STORM WHEN HE FIRST RECEIVED THE SHOCKS, THE NOISE APPEARED TO BE CAUSED BY A LEAD ISSUE, NOT AN OUTSIDE SOURCE OF EMI.

    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 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention