BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 7926780 · Received October 2, 2018

    Report

    Report Number
    2649622-2018-16063
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    February 22, 2018
    Report Date
    October 2, 2018
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169410947
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 407458 LEAD IMPLANTED: (B)(6) 2018.IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A ROUTINE CHECK, IT WAS FOUND THE PATIENT'S RIGHT ATRIAL (RA) LEAD HAD UNDERGONE A POLARITY SWITCH. THE RA LEAD WAS SWITCHED BACK TO BIPOLAR PACING AND DURING TESTING THE LEAD SHOWED NO PROBLEMS. AT THE PATIENT'S NEXT APPOINTMENT, IT WAS FOUND THE RA LEAD HAD AGAIN EXPERIENCED A POLARITY SWITCH DUE TO AN IMPEDANCE ISSUE. AGAIN THE RA LEAD WAS REPROGRAMMED BACK TO BIPOLAR AND TESTED. 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
    767213 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 457453 00643169410947

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention A2DR01 IPG