BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3992304 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09951
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 21, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATRIAL LEAD WARNING OCCURRED DUE TO HIGH IMPEDANCE; AND THE PATIENT HAD RECENTLY FALLEN ON THEIR DEVICE. IT WAS FURTHER REPORTED BY THE CLINIC THAT ATRIAL LEAD MEASUREMENTS WERE CHECKED AND FOUND TO BE WITHIN NORMAL RANGE. THE CLINIC SUSPECTED THAT ELECTROMAGNETIC INTERFERENCE (EMI) WAS THE REASON FOR THE ATRIAL LEAD ALERT. NO INTERVENTIONS WERE DONE. 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
    471845 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR ADDR01 IPG