BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1855059 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09248
    Event Type
    Injury
    Date Received
    October 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    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 THE PATIENT'S DEVICE POCKET WAS REVISED TO RELIEVE PATIENT DISCOMFORT DUE TO A PORTION OF THE UNDERLYING LEAD IN THE POCKET THAT WAS PROTRUDING AGAINST THE SKIN. IT WAS NOTED AFTER OPENING THE POCKET AND EXCISING A "LARGE MASS OF FIBROTIC ENCAPSULIZATION", THE RV LEAD HAD DAMAGE TO THE "OUTERMOST LAYER OF LEAD". THE LEAD WAS PATCHED USING A SILICONE PATCH. AFTER POCKET REVISION, THE LEADS WERE RECONNECTED TO THE DEVICE AND IT WAS NOTED THAT THE LV LEAD IMPEDANCE HAD DECREASED AND THE THRESHOLD HAD INCREASED. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS WERE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB