BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2811484 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16851
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    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. EVALUATION SUMMARY: (B)(4). THE FULL LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION WAS BREACHED CUT. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED) AND THE LEAD APPEARED DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT PROCEDURE, THERE WAS LOW LEAD IMPEDANCE. IT WAS NOTED THERE WAS BLOOD INGRESSION INSIDE THE LEAD. A HOLE WAS OBSERVED ON THE OUTER INSULATION OF THE LEAD. THE LEAD WAS ATTEMPTED AND NOT USED. ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED 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 80 YR Other