BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1991273 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02320
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    IT WAS REPORTED THAT THE ATRIAL LEAD EXPERIENCED A LEAD WARNING THE DAY OF IMPLANT AND THE VENTRICULAR LEAD EXPERIENCED A WARNING FIVE DAYS POST-IMPLANT. BOTH WARNINGS WERE TRIGGERED BY LOW IMPEDANCE THAT SWITCHED POLARITIES TO UNIPOLAR. TEN WEEKS POST-IMPLANT THE ATRIAL LEAD HAD A HIGHER UNIPOLAR IMPEDANCE THAN BIPOLAR AS WELL AS LOW THRESHOLDS. IT WAS ALLEGED THAT ONE OF THE LEADS, POSSIBLY BOTH, WAS DISLODGED. BOTH LEADS ARE STILL 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other (B)(4) IMPLANTABLE PULSE GENERATOR