BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992496 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09845
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    March 6, 2013
    Report Date
    June 12, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. CONCOMITANT PRODUCTS: 4592 LEAD, IMPLANTED: (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD APPARENTLY FRACTURED. THE LEAD WAS EXPLANTED AND NOT REPLACED. FOLLOWING THE REPLACEMENT PROCEDURE, THE PATIENT COMPLAINED OF A WORSENING CONDITION, AND A TRANSESOPHAGEAL ELECTROCARDIOGRAM (TEE) INDICATED THAT THE PATIENT'S TRICUSPID VALVE LEAFLET HAD BEEN TORN DURING THE EXPLANT PROCEDURE, RESULTING IN SEVERE TRICUSPID REGURGITATION AND A PERI-AORTIC HEMATOMA. THE PATIENT UNDERWENT OPEN-HEART SURGERY TO TREAT THE TEAR, WHICH WAS CLOSED SUCCESSFULLY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468545 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| L| R KDR901 IPG