BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992708 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09720
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 RIGHT ATRIAL (RA) LEAD IMPEDANCE HAD CHANGED FROM 400 OHMS TO 1005 OHMS BIPOLAR AND THE THRESHOLD HAD INCREASED FROM 0.4 VOLTS TO 1.4 VOLTS. IT WAS NOTED THAT THE PATIENT PREVIOUSLY HAD A MOTOR VEHICLE ACCIDENT AND DURING THE SUBSEQUENT DEVICE REPLACEMENT THAT THE RA LEAD ELECTRICAL MEASUREMENTS HAD BEEN WITHIN NORMAL RANGE. THE RA LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD SHOWED VARYING THRESHOLDS AND CONTINUING HIGH AND VARING IMPEDANCE. THE RV LEAD REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470350 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 ADDR01 IPG, 5076-52 LEAD