BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 4160652 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11792
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. CONCOMITANT MEDICAL PRODUCTS: A 457445 LEAD IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ELEVATED THRESHOLD AND IMPEDANCE VALUES WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD, AND THE DEVICE WAS SUSPECTED FOR EARLY BATTERY DEPLETION. THE LEAD WAS CAPPED AND REPLACED. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641322 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4074

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Hospitalization| R E2DR01AA IPG