BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3130380 · Received May 20, 2013

    Report

    Report Number
    3130380
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S DEVICE HAD SHOWN IT WAS TIME FOR ELECTIVE REPLACEMENT. THE PATIENT HAD TO HAVE HIS LEFT VENTRICLE (LV) LEAD TURNED OFF DUE TO DIAPHRAGMATIC STIMULATION, AND THE RIGHT VENTRICLE (RV) LEAD WAS UNDER RECALL. THE PLAN WAS FOR SYSTEM EXTRACTION AND CARDIAC RESYNCHRONIZATION DEVICE DEFIBRILLATOR (CRT-D) RE-IMPLANTATION. NOTES FROM THE OPERATIVE REPORT: "THE LEFT VENTRICULAR LEAD WAS A PASSIVE LEAD. ATTEMPT AT REMOVAL WITH MANUAL TRACTION WAS UNSUCCESSFUL. A LOCKING STYLET WAS PLACED FLUOROSCOPICALLY DOWN THE LEAD, AND THE MECHANISM WAS ENGAGED TO LOCK THE STYLET IN PLACE. A SUTURE WAS THEN SECURED AROUND INSULATION AND USING A LASER SHEATH AND MANUAL TRACTION, WE WERE ABLE TO SUCCESSFULLY REMOVE THE LEAD IN TOTAL WITHOUT EVIDENCE OF REMNANT. POINTS OF ADHESION WERE NOTED AT THE REGION OF THE CORONARY SINUS OSTIUM. A CLEARING STYLET WAS PLACED DOWN THE RIGHT VENTRICLE LEAD. THE SUTURES WERE REMOVED FROM THE SEWING RINGS. THE ACTIVE FIXATION MECHANISM WAS WITHDRAWN INTO THE LEAD. ATTEMPT AT REMOVAL WITH MANUAL TRACTION WAS UNSUCCESSFUL. A STYLET WAS PLACED FLUOROSCOPICALLY DOWN THE LEAD, AND THE MECHANISM WAS ENGAGED TO LOCK THE STYLET IN PLACE. A SUTURE WAS THEN SECURED AROUND THE INSULATION AND USING A LASER SHEATH AND MANUAL TRACTION WE WERE ABLE TO SUCCESSFULLY REMOVE THE LEAD IN TOTAL WITHOUT EVIDENCE OF REMNANT. POINTS OF ADHESION WERE NOTED AT THE JUNCTION OF THE SUPERIOR VENA CAVA AND THE PROXIMAL COIL AS WELL AS AT THE LEAD TIP-MYOCARDIAL INTERFACE." THE PATIENT TOLERATED THE PROCEDURE WELL, AND WAS DISCHARGED IN STABLE CONDITION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LEAD EXTRACTION AND CRT-D REIMPLANTATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223493 * IMPLANTABLE LWS ST. JUDE MEDICAL 1581/60 *
    223549 * IMPLANTABLE LWS ST. JUDE MEDICAL 1056T/86 *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR