BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2973392 · Received February 21, 2013

    Report

    Report Number
    2938836-2013-00145
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 18, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING NORMAL FOLLOW UP, EXTERNALIZED CONDUCTORS WERE OBSERVED VIA DIAGNOSTIC IMAGING. PATIENT WAS ASYMPTOMATIC. NO ELECTRICAL ANOMALIES WERE DETECTED. LEAD WILL BE MONITORED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT DURING DEVICE CHANGE OUT FOR NORMAL ERI, THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76868 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR