BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA

    MDR report key: 2240805 · Received August 28, 2011

    Report

    Report Number
    2240805
    Event Type
    Malfunction
    Date Received
    August 28, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 28, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A LEAD EXTRACTION DUE TO HIGH THRESHOLD AND NOISE ALONG WITH AN ICD GENERATOR REPLACEMENT AND UPGRADE TO A BIVENTRICULAR ICD. UPON INTERROGATION, HE WAS FOUND TO HAVE AN INAPPROPRIATE SHOCK. HIS GENERATOR IS NEAR ERI AND UPON FURTHER INVESTIGATION, IT WAS NOTED HIS RIGHT VENTRICULAR (RV) LEAD IS ON RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA LEAD, DEFIBRILLATION LWS ST. JUDE MEDICAL 1581 *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR