BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152539 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06770
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: ADDR03 IMPLANTABLE PULSE GENERATOR: (B)(6) 2013. 407652 IMPLANTABLE PACING LEAD: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRE-HOSPITAL DISCHARGE TEST REVEALED THE PACEMAKER SWITCHED TO UNIPOLAR PACING POLARITY FOR BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) CHANNELS. THE POLARITY WAS MANUALLY PROGRAMMED BACK TO BIPOLAR, BUT THE PACING IMPEDANCE SHOWED UNDEFINED RESISTANCE ON BOTH CHANNELS. A REVISION WAS PERFORMED WHERE IT WAS DISCOVERED THAT THERE WAS BLOOD INSIDE THE CONNECTOR OF THE PACEMAKER. AS THE PATIENT WAS IN ATRIAL FIBRILLATION (AF), IT WAS DECIDED TO EXPLANT THE RA LEAD. THE PACEMAKER WAS EXPLANTED AND CHANGED TO A SINGLE CHAMBER SYSTEM. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253164 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R