BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTRONIK

    MDR report key: 517056 · Received March 10, 2004

    Report

    Report Number
    MW1031483
    Event Type
    Injury
    Date Received
    March 10, 2004
    Date of Event
    July 3, 2002
    Report Date
    March 9, 2004
    Manufacturer
    BIOTRONIK INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PERMANENT PACEMAKER ATRIAL LEAD REPOSITIONING AND REPLACEMENT VIA LEFT SUBCLAVIAN VEIN AND PECTORAL POCKET. INDICATION: ATRIAL LEAD MALFUNCTION. PROCEDURAL DESCRIPTION. THE ATRIAL LEAD WAS FREED FROM THE GENERATOR HEADER WITH THE WRENCH PROVIDED. MULTIPLE CLICKS WERE HEARD EACH TIME THE WRENCH WAS TURNED. THE LEAD WAS REMOVED FROM THE HEADER. THE VENTRICULAR LEAD WAS SIMILARLY REMOVED AND THE GENERATOR SET ASIDE. THE ATRIAL LEAD WAS FREED FROM ITS ADHESIONS USING THE BOVIE. THE ANCHORING SUTURES WERE CUT, TAKING CARE NOT TO INJURE THE LEADS. THE SUTURES WERE REMOVED. THE CURVED STYLET WAS UTILIZED TO MANIPULATE THE ATRIAL LEAD TO VARIOUS POSITIONS. UNABLE TO GET ADEQUATE THRESHOLDS. THE LEAD EVENTUALLY FAILED TO EXTEND ITS FIXATION HELIX AND FOR THIS REASON, THE LEAD WAS REMOVED. THE LEFT SUBCLAVIAN VEIN WAS THEN ACCESSED WITH A 16 GAUGE NEEDLE. A WIRE WAS PLACED IN THE NEEDLE. THE NEEDLE WAS EXCHANGED OVER THE WIRE FOR A 9 FRENCH PEEL-AWAY SHEATH. THE SHEATH WAS ENTERED WITH A NEW LEAD. THE LEAD WAS MANIPULATED TO THE RIGHT ARTERIAL APPENDAGE. A CURVED STYLET WAS UTILIZED. IT WAS AFFIXED TO THE ENDOCARDIUM PER THE MFR'S SPECIFICATIONS. THE THRESHOLDS WERE TESTED AND FOUND TO BE EXCELLENT. THE LEADS WERE THEN ANCHORED TO THE BASE OF THE POCKET USING THE 0 SILK THROUGH THE SEWING RING PROVIDED. THE SHEATH WAS PEELED AWAY. SLACK WAS VERIFIED UNDER FLUOROSCOPY. NEXT THE GENERATOR WAS BROUGHT BACK ONTO THE FIELD AND CONNECTED TO THE LEADS IN THE APPROPRIATE POSITIONS. MULTIPLE CLICKS WERE HEARD EACH TIME THE WRENCH WAS TURNED. THE LEADS WERE TESTED FOR STABILITY WITH GENTLE TRACTION TO VERIFY THAT THEY WERE STABLE IN THE GENERATOR HEADER. NEXT, THE POCKET WAS WASHED WITH DOUBLE ANTIBIOTIC SOLUTION. IT WAS INSPECTED FOR BLEEDERS. THOSE FOUND WERE EITHER BOVIED OR TIED OFF AS THEY WERE FOUND. NEXT, THE PACEMAKER GENERATOR WAS PLACED BACK IN THE POCKET WITH EXCESS LEAD COILED UNDER IT. THE GENERATOR WAS ANCHORED TO THE PACEMAKER POCKET USING 0 SILK THROUGH THE SEWING RING PROVIDED. THE POCKET WAS THEN CLOSED WITH 2-0 VICRYL IN TWO SEPARATE LAYERS. THE SKIN WAS THEN APPROXIMATED WITH DERMABOND. AT THIS POINT, THE PROCEDURE WAS TERMINATED. FINDINGS: 1-ATRIAL THRESHOLD. 1.0 AT 3.5 MS. 2-P WAVE: 2.2 MV. 3-IMPEDANCE: 888 OHMS. 4-BIOTRONIK LEAD REMOVED: 5-ATRIAL LEAD IMPLANTED: GUIDANT SWEET TIP. MODEL 4244, IMPRESSION: 1-SUCCESSFUL PERMANENT PACEMAKER LEAD REPLACEMENT. 2-MALFUNCTION OF ORIGINAL ATRIAL LEAD. 3-SUCCESSFUL ATRIAL LEAD EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOTRONIK IMPLANTABLE CARDIAC PACEMAKER DXY BIOTRONIK INC. BA03DDDR *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R| S