BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1921114 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12370
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 PATIENT'S RIGHT ATRIAL (RA) PACE/SENSE LEAD HAD CAUSED THE DEVICE TO SWITCH FROM BIPOLAR TO UNIPOLAR PACING DUE TO HIGH PACING IMPEDANCES. IT WAS ALSO REPORTED THAT THERE WAS OVERSENSING. THE PATIENT IS BEING EVALUATED TO SEE IF THE LEAD NEEDS TO BE REPLACED AS THE PATIENT'S NEED FOR PACING IS NO LONGER CLEAR. THERE WERE NO PATIENT COMPLICATIONS 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other