BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152509 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06771
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. CONCOMITANT PRODUCT: 4193 IMPLANTABLE PACING LEAD (B)(6) 2005; 4574 IMPLANTABLE PACING LEAD (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO CAPTURE WITH THE RIGHT VENTRICULAR (RV) LEAD AND THE RV LEAD EXHIBITED HIGH THRESHOLD DURING TESTING. THE RV LEAD WAS PROGRAMMED TO VVO MODE AT MAX OUTPUTS AND SUBSEQUENTLY REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253137 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Hospitalization| L| R C4TR01 IMPLANTABLE PACEMAKER CARDIO/DEFIB