BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 4776238 · Received May 15, 2015

    Report

    Report Number
    2025587-2015-00564
    Event Type
    Injury
    Date Received
    May 15, 2015
    Date of Event
    April 2, 2012
    Report Date
    May 20, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LDF
    PMA / PMN Number
    K012458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: AORTIC BLEEDING ONE WEEK AFTER REMOVAL OF AN INTRAOPERATIVE EPICARDIAL TEMPORARY PACING WIRE AUTHORS: TSUTOMU MATSUSHITA, HARUKI FUSE, KAZUO TAKEUCHI, SHINSUKE MASUDA AND TOMOYA INOUE JOURNAL CITATION: ANN THORAC CARDIOVASC SURG 2013; 19: 231¿233 (DOI: 10.5761/ATCS.CR.12.01886). (B)(4).

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT HAD AN AWARE DATE OF (B)(6) 2015, AND HAS BEEN CORRECTED TO (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION IDENTIFIED THE PACING LEAD AS MODEL 6495J (SERIAL NOT REPORTED). THE PRODUCT IS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT (B)(6) MALE PATIENT UNDERWENT A LEFT NEPHRECTOMY WITH RESECTION OF A CAVOATRIAL TUMOR THROMBUS UNDER A CARDIOPULMONARY BYPASS ASSIST FOR LEFT RENAL CELL CARCINOMA. A MEDTRONIC BIPOLAR TEMPORARY EPICARDIAL ATRIAL PACING LEAD (MODEL/SERIAL NOT REPORTED) WAS USED BOTH INTRAOPERATIVE, FIXED WITH POLYPROPYLENE SUTURES AT THE RIGHT ATRIAL APPENDAGE, AND POSTOPERATIVE DURING RECOVERY. EIGHT DAYS POSTOPERATIVE THE TEMPORARY PACING LEAD WAS REMOVED WITHOUT ISSUE. FIFTEEN DAYS POSTOPERATIVE THE PATIENT COLLAPSED. EMERGENT TRANSTHORACIC ECHOCARDIOGRAPHY AND COMPUTED TOMOGRAPHY SCANNING DETECTED CARDIAC TAMPONADE WITH AND BLEEDING FROM THE AORTIC ROOT. UPON EMERGENT INTERVENTION, ACTIVE ARTERIAL BLEEDING FROM THE AORTIC ROOT DISTAL TO THE SITES OF CANNULATION AND CARDIOPLEGIA WAS CONFIRMED, AND HEMOSTASIS WITH SUTURES WAS COMPLETED. THE PATIENT RECOVERED WELL AND WAS DISCHARGED. IN THE AUTHOR¿S OPINION, THIS LATE BLEEDING COMPLICATION WAS INITIATED DURING LEAD REMOVAL, WHERE LEAD TIP PRESSURE CREATED AN AORTIC WALL EROSION WHICH GRADUALLY RESULTED IN A PINHOLE RUPTURE IN THE AORTA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318763 MEDTRONIC ELECTRODE, PACEMAKER, TEMPORARY LDF MEDTRONIC HEART VALVES DIVISION 6495J

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Life Threatening| R