BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1991318 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02348
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DURING AN UPGRADE TO A NEW DEFIBRILLATOR, THE PATIENT'S ATRIAL LEAD DISLODGED AND WAS REPOSITIONED. DURING THE REPOSITIONING, THE RIGHT VENTRICULAR AND LEFT SUPERIOR VENA CAVA COILS MEASURED WITH IMPEDENCE OVER 200 OHMS. SEVERAL DAYS LATER, THE PATIENT ALERT TRIGGERED. IN MEASURING THE LEAD FROM THE LEFT VENTRICULAR TIP TO THE RIGHT VENTRICULAR COIL, IMPEDENCE WAS OVER 3000 OHMS. UPON X-RAY, A LEAD FRACTURE WAS FOUND IN THE RIGHT VENTRICULAR LEAD. THE LEAD REMAINS IMPLANTED. 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB