BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2812563 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16936
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    February 4, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED BASED ON INTERNAL REPORTING THAT THE LEAD WAS IMPLANTED AFTER THE USE BY DATE HAD EXPIRED. THE LEAD HAS SINCE BEEN EXPLANTED AND REPLACED DUE TO AN ASSOCIATED LEAD AND NO PERFORMANCE PROBLEMS WERE NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT EVENT SUMMARY:THE FULL LEAD WAS RETURNED IN SEGMENTS. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS DETERMINED BASED ON INTERNAL REPORTING THAT THE LEAD WAS IMPLANTED AFTER THE USE BY DATE HAD EXPIRED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS DETERMINED BASED ON INTERNAL REPORTING THAT THE LEAD WAS IMPLANTED AFTER THE USE BY DATE HAD EXPIRED. THE LEAD HAS SINCE BEEN EXPLANTED AND REPLACED DUE TO AN ASSOCIATED LEAD AND NO PERFORMANCE PROBLEMS WERE NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| R D274TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD