BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2952543 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00599
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    July 9, 2012
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL END ELECTRODE WAS COVERED WITH BLOOD AND THE OUTER INSULATION OF THE LEAD WAS CUT. A VISUAL SUMMARY NOTED APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED: 6944 IMPLANTABLE DEFIBRILLATION LEAD (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH THRESHOLDS AND EXIT BLOCK WERE OBSERVED IN THE RIGHT ATRIAL LEAD. THE LEAD WAS INITIALLY REPOSITIONED AND LATER EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56511 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIODEFIBRILLATOR