BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992291 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09968
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    November 1, 2013
    Report Date
    July 13, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WARNING TRIGGERED TEN MONTHS PRIOR, AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOSS OF CAPTURE WITH ISOMETRICS AND A POLARITY SWITCH. RECENT REVIEW OF THE RV LEAD MEASUREMENTS INDICATES NORMAL FUNCTION, HOWEVER THE ATRIAL LEAD NOW EXHIBITS HIGH IMPEDANCES AND INHIBITION WAS NOTED WITH ISOMETRICS. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENTS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS, HIGH IMPEDANCE AND A LEAD FRACTURE WAS CONFIRMED. THE LEAD HAS BEEN CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468566 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R