BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 9936938 · Received April 8, 2020

    Report

    Report Number
    2649622-2020-07203
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    February 21, 2020
    Report Date
    April 20, 2020
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ADDR01 IPG IMPLANT DATE (B)(6) 2010. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE RA LEAD IMPEDANCE WAS CHRONICALLY LOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED AN IMPEDANCE WARNING. IT WAS FURTHER REPORTED THAT THE RA LEAD EXHIBITED O VER-SENSING. THE RA 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
    402009 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4524-53

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR