BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2810448 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15734
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT'S SPOUSE REPORTED THAT THE "FAULTY LINE" WAS KEPT IN EVEN THOUGH THE DEVICE WAS CHANGED OUT. IT WAS NOT SPECIFIED WHICH LEAD WAS BEING REFERRED TO. THE SPOUSE DID NOTE THAT THE PATIENT IS IN HOSPICE ALONG WITH HAVING HEART, KIDNEY AND LUNG ISSUES. NO FURTHER INFORMATION ON THE EVENT WAS ABLE TO BE OBTAINED. THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other D274DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB