BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP 4024

    MDR report key: 3153393 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05982
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    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 RIGHT VENTRICULAR (RV) BIPOLAR LEAD IMPEDANCE WAS LOW AND A WARNING TRIGGERED. UNIPOLAR IMPEDANCE WAS HIGHER AND UNIPOLAR THRESHOLD WAS BETTER AS WELL. THE LEAD WAS SWITCHED TO UNIPOLAR PACING AND WILL CONTINUE TO BE MONITORED. 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
    258905 CAPSURE SP 4024 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention SESR01 IMPLANTABLE PULSE GENERATOR (IPG)