BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC 6949

    MDR report key: 1183085 · Received September 23, 2008

    Report

    Report Number
    1183085
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    May 20, 2008
    Report Date
    September 23, 2008
    Manufacturer
    MEDTRONIC INC. CARDIAC RHYTHM DISEASE MANAGEMENT
    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 HAD A HISTORY OF CORONARY BYPASS GRAFTING IN THE PAST. HE DEVELOPED A DILATED ISCHEMIC CARDIOMYOPATHY WITH AN EJECTION FRACTION OF 25% AND UNDERWENT ICD IMPLANTATION OF A SINGLE LEAD ON THE RIGHT SIDE IN THE PAST YEAR. THE PATIENT'S ICD PLACEMENT WAS COMPLICATED BY DIFFICULT VENOUS ACCESS. IT WAS DEMONSTRATED TO HAVE AN OCCLUSION ON THE LEFT SIDE. THE PATIENT NOW HAS HAD SIX INAPPROPRIATE SHOCKS AND HAS THE RECALLED FIDELIS LEAD. HE WAS REFERRED HERE BY HIS IMPLANTING CARDIOLOGIST BECAUSE OF THE NEED FOR LEAD EXTRACTION AND THE POSSIBILITY OF DIFFICULTIES AGAIN WITH VENOUS ACCESS. OP NOTE: WE WERE ABLE TO CANNULATE THE RIGHT SUBCLAVIAN VEIN LATERALLY ON THE FIRST PASS WITHOUT DIFFICULTY. WE ADVANCED THE GUIDEWIRE UNDER FLUOROSCOPE INTO THE RIGHT HEART. WE OPENED THE ICD POCKET THROUGH THE EXISTING INCISION EXCISING THIS SCAR. THEICD WAS DELIVERED INTO THE WOUND. THE LEADS WERE DISSECTED FREE FROM THEIR ADHESIONS WITHIN THE FIBROUS CAPSULE AND THE SUTURE FIXATION TO THE CHEST WALL WAS ALSO DIVIDED. WE WERE UNABLE TO PASS THE STYLET DOWN THIS OLD DEFIBRILLATOR LEAD. WE WENT THROUGH THE ACTIVE FIXATION DEVICE AND USING CONSTANT GENERAL TRACTION REMOVED THE LEAD IN ITS ENTIRETY. THE ONLY AREA WHERE THELEAD APPEARED TO OFFER ANY RESISTANCE WAS AT THE CAVOATRIAL JUNCTION. EXAMINATION OF THE LEAD SHOWED THERE TO BE A BREAK AT THE DISTAL COIL. WHETHER THIS WAS PRESENT PRIOR TO EXTRACTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC 6949 LEAD, ICD LWS MEDTRONIC INC. CARDIAC RHYTHM DISEASE MANAGEMENT 6949 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR CARDIAC DRUGS| CARDIAC DRUGS