BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 3992100 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10044
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THERE WAS A LEAD WARNING ON THE RIGHT VENTRICULAR LEAD. THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR STATUS SO IT WAS NOT CLEAR WHAT THE LEAD ISSUE WAS. THE PHYSICIAN SURMISED THE LEAD IMPEDANCE MEASUREMENT WAS LOW AS THE IMPEDANCE HAD BEEN MEASURING ON THE LOWER END. THE LEAD TESTED FINE WHEN THE DEVICE WAS CHANGED OUT. THE LEAD REMAINS IN USE AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE LEAD PERFORMANCE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471207 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407452

    Patients

    Seq Age Sex Outcome Treatment
    1 00097 YR E2DR01AA IPG, 4574-52 LEAD