BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3151580 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05492
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. CONCOMITANT PRODUCTS: ADDRL1 IMPLANTABLE PULSE GENERATOR (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR LEAD DISLODGED APPROXIMATELY ONE WEEK AFTER IMPLANT. THE LEAD WAS REPOSITIONED. THE RIGHT ATRIAL LEAD ALSO DISLODGED. THE DEVICE WAS INITIALLY REPROGRAMMED TO VVI MODE AND LATER EXPLANTED AND REPLACED WHEN THE SYSTEM WAS MOVED TO THE RIGHT SIDE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252133 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD