BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 3992191 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09992
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 FURTHER REPORTED THAT THE LEAD IMPEDANCE CONTINUES TO INCREASE. A CHEST X-RAY INDICATED THAT THE LEAD LOOKED "FINE WITH NO FRACTURE." NO NOISE OR OVERSENSING WAS NOTED WITH ISOMETRICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE HAS BEEN RISING SINCE APRIL. CAPTURE AND R-WAVE SENSING REMAIN THE SAME, AND THERE IS NO EVIDENCE OF NOISE OR OVERSENSING. THE LEAD REMAINS IN USE AND THE CLINIC WILL MONITOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468944 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407452

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR ADSR01 IPG