BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3062206 · Received April 16, 2013

    Report

    Report Number
    2649622-2013-05086
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO BE NOT CAPTURING ONE DAY POST IMPLANT. THE LEAD WAS REPOSITIONED AND CAPTURING OCCURRED WITHOUT DIFFICULTY. IT WAS ALSO REPORTED THAT WHILE THE LEAD WAS OUT OF THE DEVICE HEADER, A POLARITY SWITCH OCCURRED ON THE RV LEAD. THE LEAD WAS PLACED INTO THE HEADER AND THE DEVICE WAS PLACED IN TH POCKET AND THE LEAD WAS NOT FUNCTIONING UNTIL IT WAS REPROGRAMMED BACK TO BIPOLAR. THE 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
    163951 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ADVDD01 IMPLANTABLE PULSE GENERATOR (IPG)