BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3860749 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05324
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. CONCOMITANT MEDICAL PRODUCTS: 5054-58, LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHECK, THE ATRIAL LEAD IMPEDANCE WAS NOTED TO HAVE INCREASED TO 3231 OHMS RESPECTIVELY. AN X-RAY WAS TAKEN AND A CLEAR LEAD FRACTURE WAS DETECTED. THE PATIENT WAS SENT TO THE HOSPITAL FOR REPLACEMENT, HOWEVER THE PHYSICIAN DECIDED NOT TO PERFORM A REVISION DUE TO THE PATIENT'S CONDITION. THE DEVICE WAS PROGRAMMED TO A SINGLE CHAMBER MODE INSTEAD. THE ATRIAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337190 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO OPERATIONS 5554-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention ADDRL1 IPG