BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2810147 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15644
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    July 1, 2012
    Report Date
    October 29, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE AND FOLLOW UP WITH THE AUTHOR. THIS EVENT OCCURRED OUTSIDE THE US. THE EVENT WILL BE REPORTED VIA 30D TIME LINE DUE TO THE PATIENT MEAN AGE OF (B)(6) YEARS. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: SILVETTI MS, DRAGO F, RAV L. "LONG-TERM OUTCOME OF TRANSVENOUS BIPOLAR ATRIAL LEADS IMPLANTED IN CHILDREN AND YOUNG ADULTS WITH CONGENITAL HEART DISEASE." EUROPACE. JULY 1 2012;14(7):1002-1007..

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEAD. THE FAILURE MODE NOTED IN THE ARTICLE FOR THE LEAD WAS DISLODGEMENT. THE ARTICLE STATED THAT THE DISLODGED LEADS IN THIS ARTICLE WERE REPOSITIONED, EXPLANTED, OR ABANDONED. HOWEVER, THE SPECIFIC INTERVENTION AND THE STATUS FOR THIS PARTICULAR LEAD ARE UNKNOWN. NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Death