BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3992667 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09746
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 PATIENT EXPERIENCED POCKET STIMULATION SEVERAL TIMES PER DAY, AND ALSO UPON INTERROGATION, BUT ONLY WHEN PROGRAMMED TO HIGHER OUTPUTS. THE LEAD WAS TESTED AND ALL VALUES WERE STABLE AND GOOD, WITH THE LEAD PROGRAMMED TO BIPOLAR. THE LEAD CHRONIC IMPEDANCE TREND DIAGNOSTIC WAS TURNED OFF 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
    469278 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068-52

    Patients

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