BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1010591 · Received March 10, 2008

    Report

    Report Number
    2017865-2008-01231
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    January 28, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A LEAD TIP STIFFNESS TEST WAS PERFORMED AND FOUND TO BE WITHIN SPECIFICATION. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2010-02559. IT WAS REPORTED THAT DURING A NEPHROURETERAL STENTING PROCEDURE A TEAR OCCURRED IN THE IE TEMP TIP 8/26. THEY WERE PLACING THE DEVICE WITH A NON BSC WIRE. THE DEVICE WAS PLACED IN THE PATIENT AND THE PHYSICIAN INJECTED DYE AND NOTICED IT WAS LEAKING. THE DEVICE TORE NEAR THE PROXIMAL HOLES. THEY USED ANOTHER IE TEMP TIP 8/26 AND AS THEY PLACED THIS ONE THE PHYSICIAN NOTICED THAT IT DID NOT LOOK RIGHT. HE INJECTED CONTRAST AND COULD SEE THAT THE DEVICE HAD TORN ON THE CATHETER PROXIMAL TO THE SIDE HOLES. THE PROCEDURE WAS COMPLETED WITH A IE TEMP TIP 22/138. THE PATIENT STATUS IS LISTED AS OK WITH NO COMPLICATIONS REPORTED.

    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