BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST PASSIVE FIXATION

    MDR report key: 1223627 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03591
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 11, 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

    THE REPORTED FIELD EXPERIENCE WAS CONFIRMED. ANALYSIS REVEALED AN ABRASION THROUGH THE OUTER INSULATION AT 17.4CM EXPOSING ONE OF THE SENSING CABLES. THE LEAD ABRASION IS CONSISTENT WITH THAT PRODUCED BY FRICTION WITH THE ICD CAN. THE ELECTRICAL CHARACTERISTICS OF THE LEAD WERE FOUND TO BE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP, NOISE WAS OBSERVED. HENCE, THE LEAD WAS EXPLANTED. LEAD DAMAGE WAS OBSERVED ON OUTER INSULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST PASSIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7040/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention