BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2813377 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16270
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 ATRIAL LEAD HAD UNDEFINDED LEAD IMPEDANCE IN BOTH UNIPOLAR AND BIPOLAR. THE LEAD WAS UNABLE TO SENSE IN THE UNIPLOAR CONFIGURATION AND WAS UNABLE TO CAPTURE IN BOTH CHAMBERS. IT ALSO SHOWED INTERMITTENT OVERSENSING OF THE R WAVES AND HAD OTHER SENSING ISSUES. AT THE LEAD REVISION, IT WAS FOUND THAT THE LEAD WAS NOT WELL CONNECTED INTO THE DEVICE HEADER. THE LEAD WAS RESEATED AND THE DEVICE AND LEAD REMAIN 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
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R