BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1050821 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01767
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    February 5, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. A PARTIAL LEAD WAS RETURNED FOR EVALUATION. WITHOUT THE ENTIRE LEAD, A COMPLETE EVALUATION COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMP. INFLOW CANNULA MALPOSITION SINCE WEIGHT LOSS. SPECIFIC COMPONENT(S) INVOLVED: INFLOW GRAFT MALFUNCTION/MALPOSITION. CANNULA HAS MOVED LATERALLY. CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. INTERVENTION(S): NONE. IMPLANT DEVICE TYPE: LVAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO NOISE ON THE VENTRICULAR LEAD. UPON FOLLOW- UP, IT WAS NOTED THAT THE PATIENT WILL BE TREATED WITH MEDICATION AND THE LEAD WILL REMAIN IMPLANTED..

    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