BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1223246 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03705
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 25, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE EVENT REPORTED IN THE FIELD WAS VERIFIED IN THE LABORATORY. THE OUTER INSULATION AND THE ETFE INSULATION OF ONE OF THE SENSING CABLES WERE ABRADED AND DAMAGED, AS A RESULT OF FRICTION WITH THE ICD CAN. NORMAL ELECTRICAL CHARACTERISTICS WERE MEASURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY, DUE TO AN INSULATION BREAK ON THE LEAD. AT EXPLANT, SIGNS OF WEAR WERE NOTED ON THE PART OF THE LEAD THAT WAS UNDERNEATH THE ICD CAN.

    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 Required Intervention