BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6161766 · Received December 9, 2016

    Report

    Report Number
    2649622-2016-14790
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    July 26, 2016
    Report Date
    September 28, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. CONCOMITANT PRODUCT: M7700-29 MECHANICAL HEART VALVE IMPLANTED: (B)(6) 1990.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED FOR UNKNOWN REASONS. THE LEADS SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809110 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR ADDR01 IPG, 407652 LEAD