BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3860034 · Received June 10, 2014

    Report

    Report Number
    3008973940-2014-00165
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 12, 2014
    Report Date
    April 7, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, WHEN THE HELIX OF THE RIGHT VENTRICULAR (RV) LEAD WAS SCREWED INTO THE MYOCARDIUM THERE WAS WEAK OR NO SENSING AND NO CAPTURE. THE IMPEDANCE WAS WITHIN RANGE BUT ALL OTHER MEASUREMENTS WERE NOT ACCEPTABLE. ANOTHERLEAD WAS IMPLANTED AND THIS LEAD WAS REMOVED. AFTER THE PROCEDURE THE PATIENT¿S CONDITION DETERIORATED AND AN ECHOCARDIOGRAM SHOWED PERICARDIAL FLUID, RV PERFORATION WAS SUSPECTED. THE PATIENT WAS TREATED AND RECOVERED QUICKLY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340235 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention