BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3862347 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06894
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    March 24, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 THAT THE THRESHOLDS AND IMPEDANCE HAVE RISEN OVER THE PAST FEW MONTHS ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THERE WAS HIGH THRESHOLD AND POSSIBLE FRACTURE. THE LEAD WAS CAPPED 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
    338051 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407458

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Hospitalization| R ADSR01 IPG