BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2810628 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16278
    Event Type
    Malfunction
    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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THERE WAS AN OUT OF RANGE IMPEDANCE ALERT WITH A SPIKE IN IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR AND SUPERIOR VENA CAVA COILS. THE IMPEDANCE MEASUREMENTS WERE HIGH AND HAVE SINCE BEEN STEADY AND RETURNED TO HISTORICAL VALUES. IT WAS ALSO NOTED THE ATRIAL LEAD IMPEDANCE HAS BEEN SPIKING INTERMITTENTLY. THE RIGHT VENTRICULAR LEAD WAS REPLACED DUE TO FRACTURE. THE ATRIAL LEAD REMAINS 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 64 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD