BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1010677 · Received March 10, 2008

    Report

    Report Number
    2017865-2008-01138
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    January 17, 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
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS NOTED ABRASIONS ON THE LEAD BODY AT 16 AND 18 CM FROM THE CONNECTOR. THE IS-1 PROXIMAL CABLES WERE EXPOSED AT 16 CM AND ONE OF THE CABLE'S ETFE INSULATION WAS ABRADED AND THE CABLE WAS MELTED. THE ABRASIONS ARE INDICATIVE OF EXPOSURE TO FRICTION WITH THE ICD CAN. NORMAL ELECTRIAL CHARACTERISTICS WERE MEASURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLE PROCEDURE, THE FIRST DEVICE WAS STUCK ON THE DUCT AND THEY HAD TO PULL IT OFF. THE SECOND DEVICE WAS STUCK ON THE DUCT AND HAD TO BE PULLED OFF THE DUCT. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE, BUT THEY DID NOT KNOW HOW IT WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. (B) (4).

    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 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention