BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1050656 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01618
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 19, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE .

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, 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 LEAD WAS REMOVED DUE TO NOISE AND A SENSING ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention