BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2955228 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-00799
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 CONTINUED: 5076 IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD IS SUSPECTED TO BE DISLODGED. IT WAS DESCRIBED THAT AP (ATRIAL PACE) IMMEDIATELY FOLLOWED BY VS (VENTRICULAR SENSE) AND VP (VENTRICULAR PACE). IT WAS NOTED THAT WHEN PATIENT PACED AOO (ATRIAL NONE NONE) IT WAS CAPTURING THE VENTRICLE. THE LEAD REMAINS IN USE AND A CHEST X-RAY WAS RECOMMENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58386 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00093 YR ADDR01 IMPLANTABLE PULSE GENERATOR