BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3993865 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09079
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. CONCOMITANT PRODUCTS: 5524M45 LEAD, IMPLANTED 1998 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISEN AND FLUCTUATED THRESHOLDS. IT WAS ALSO OBSERVED THAT CAPTURE MANAGEMENT WAS ADAPTED TO HIGH OUTPUTS. REPROGRAMMING WAS PERFORMED. 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
    469401 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention SEDR01 IPG