BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991613 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08012
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE RIGHT VENTRICULAR (RV) LEAD DISLODGED WHILE THE PHYSICIAN IMPLANTED THE ATRIAL LEAD. DUE TO TIGHTNESS AROUND THE CLAVICLE THE PHYSICIAN COULD NOT REPOSITION THE RV LEAD. THE RV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470875 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR