BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2790723 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15056
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS IN CHRONIC ATRIAL FIBRILLATION (AF) AND THAT THE ATRIAL LEAD PREVIOUSLY DISLODGED. ADDITIONALLY, DURING DEFIBRILLATION THRESHOLD (DFT) TESTING INTERNAL SHOCKS FAILED TO CONVERT THE RHYTHM; HOWEVER AN EXTERNAL SHOCK WAS SUCCESSFUL, CONVERTING THE HEART OUT OF VENTRICULAR FIBRILLATION (VF) AND AF. THE RV AND ATRIAL LEADS WERE BOTH REPOSITIONED. POST REPOSITIONING, ADDITIONAL DFT WAS PERFORMED, AND AN INTERNAL SHOCK WAS SUCCESSFUL IN CONVERTING THE RHYTHM. IT WAS ALSO REPORTED THAT DURING FOLLOW UP THE PATIENT COMPLAINED OF CHEST DISCOMFORT FROM THE RV LEAD AND ATRIAL LEAD. THEREFORE THE RV LEAD WAS REPOSITIONED FROM THE APEX TO THE RV SEPTUM AND THE ATRIAL LEAD WAS REPOSITIONED FROM THE ANTERIOR LATERAL WALL TO THE RA APPENDAGE. THE RV AND ATRIAL LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R 4196 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB