BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991757 · Received August 8, 2014

    Report

    Report Number
    3008973940-2014-00257
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 7, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME 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, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER THE RIGHT VENTRICULAR (RV) LEAD WAS POSITIONED TESTING REVEALED HIGH IMPEDANCE WITH A POSSIBLE FRACTURE. THE TESTING CABLE WAS CHANGED OUT HOWEVER THE IMPEDANCE PROBLEM PERSISTED. THE RV LEAD WAS REPOSITIONED AND THE PROBLEM STILL PERSISTED. MORE THAN THREE DIFFERENT POSITIONS WERE ATTEMPTED YET THE PROBLEM REMAINED. THE RV LEAD WAS REMOVED, EXCHANGED FOR A DIFFERENT LEAD AND THERE WAS NORMAL THRESHOLD AND IMPEDANCE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467395 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR