BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 3160318 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07945
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD, THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    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 PRODUCTS: 5076 IMPLANTABLE PACING LEAD (B)(6) 2013. (B)(4).

    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 SHORTLY AFTER IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD HAD NO VENTRICULAR CAPTURE. A LEAD DISLODGEMENT WAS CONFIRMED AND REPOSITIONING WAS ATTEMPTED, BUT THE LEAD COULD NOT ADVANCE DUE TO PATIENT ANATOMY. THE LEAD WAS EXPLANTED AND REPLACED WITH A LONGER LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259737 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R VEDR01 IMPLANTABLE PULSE GENERATOR (IPG)