BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 4161756 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11428
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 9, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.,
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT WAS LAST SEEN, THE DEVICE INDICATED 15 MONTHS FOR A 95TH PERCENTILE FOR BATTERY LONGEVITY AND 7 MONTHS FOR LOW END. THE DEVICE HAD TRIPPED ELECTIVE REPLACEMENT INDICATOR (ERI) IN LESS THAN THE EXPECTED TIME. THE PATIENT IS BOOKED ON AN URGENT DEVICE REPLACEMENT. IT WAS NOTED THERE WAS HIGH AND INCREASED THRESHOLD ON THE RIGHT VENTRICULAR (RV) LEAD. THE DEVICE WAS REPROGRAMMED AND THE 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
    639140 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO OPERATIONS CO., 407458

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention SESR01 IPG