BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2791291 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15427
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD HAD AN EPISODE OF HIGH RESISTANCE BUT DURING A CHECKUP THE IMPEDANCE APPEARED WITHIN NORMAL RANGE. IT WAS ALSO NOTED THAT THE ATRIAL LEAD HAD SOME CHANGES IN THE SENSING VALUE. A HOLTER MONITOR FOUND NOISE AND PACING FAILURE IN THE ATRIAL HIGH RATE EPISODE. THE LEAD WAS PROGRAMMED OFF AND REMAINS IMPLANTED. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5554

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR| 5054 IMPLANTABLE PACING LEAD