BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3864727 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07546
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. PRODUCTS: 5568-45 LEAD, IMPLANTED: 2003 (B)(6) (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SYMPTOMS OF SYNCOPE, WAS VERY TIRED, AND WAS IN ATRIAL FIBRILLATION (AF). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DEMONSTRATED HIGH BIPOLAR THRESHOLD, LOW IMPEDANCE, AND OVERSENSING. IT WAS NOTED THAT THERE WAS INAPPROPRIATE INHIBITION OF PACING. THE LEAD WAS INITIALLY REPROGRAMMED. SUBSEQUENTLY, THE LEAD WAS CAPPED AND WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338261 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| L| R ADDR01 IPG