BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE-FIXATION LEAD

    MDR report key: 804348 · Received January 10, 2007

    Report

    Report Number
    2017865-2007-00160
    Event Type
    Injury
    Date Received
    January 10, 2007
    Date of Event
    November 30, 2006
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO A LEAD DISLODGEMENT. THE LEAD WAS REPOSITIONED ON 08/02/2006.

    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 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention